FDA shoots warning across bow of CanadaDrugs.com

FDA shoots warning across bow of CanadaDrugs.com

The FDA has sent a warning letter to one of the most prolific Internet drug providers from Canada, which reports have tied to an investigation of counterfeits of the cancer drug Avastin that were sold to physician practices in the U.S. this year.The agency this week posted a warning letter sent to a lawyer in Manitoba claiming that hundreds of websites it identified, including CanadaDrugs.com, were offering for sale drugs made at unapproved facilities. It said the sites were even offering domperidone, which it said is no longer approved for sale in the U.S. because of dangers to breastfeeding women. 
A similar warning letter regarding "Arkadiy Kisin/White Forest Solutions" was also sent to a series of email addresses and lists dozens of Internet pharmacy sites offering contraceptives and "unapproved drugs" including Accutane, which it says has not been approved for sale in the U.S. since 2010. 
An investigation this year by The Wall Street Journal tied the owner of CanadaDrugs.com, Kris Thorkelson, to a probe by federal authorities into companies that the FDA said supplied counterfeit Avastin to U.S. doctors. It said subpoenas sent to physicians asking for information about where they obtained the drugs named Thorkelson. The warning letter says, the "FDA is taking this action against your firm because of the inherent risk in buying unapproved and misbranded new drugs." It gives the companies 10 days to respond.The FDA in February and April discovered the counterfeit cancer drugs. Some of the recovered boxes were labeled Altuzan, which is the brand name for Avastin in Turkey. Tests, however, determined that there was no active ingredient in the counterfeits. So far, there have been no reports of problems related to the drugs, according to the FDA and Genentech, the Roche ($RHHBY) unit that makes the cancer treatment.The letter came only days after the agency launched a new campaign it hopes will discourage the practice of buying drugs online, or at least, teach consumers how to determine what sites are potentially legit. The agency last week launched BeSafeRx, to warn against the dangers.- here's the warning letter to CanadaDrugs.com
- here's the letter to Arkadiy Kisin/White Forest SolutionsRelated Articles:
Fake of Roche's Avastin shipped from Canadian supplier
Phony Avastin vials contained chemicals, but no drugs
Avastin alert likely to revive discussion of pharma-financed tracking system
U.S. market size, shortages lead to more counterfeits
FDA tries to teach consumers of Internet dangers read more..

source:http://www.fiercepharmamanufacturing.com/

Food Safety Modernization Act-Center For Food Safety-Regulations-Provisions-Fsma

FDA and OMB Sued Over Delays in FSMA Implementation

By Ricardo Carvajal –The Center for Food Safety and the Center for Environmental Health filed suit in the Northern District of California to compel FDA and the Office of Management and Budget (“OMB”) to implement several major provisions of the Food Safety Modernization Act (“FSMA”). Those provisions require rulemaking to establish or provide for:

• Hazard analysis and risk-based preventive controls
• Clarification of activities that subject a farm to facility registration requirements
• Science-based minimum standards for the safe production and harvesting of fresh fruits and vegetables
• Protection against intentional adulteration
• Sanitary transportation of food
• Foreign supplier verification
• Standards for third-party audits

The suit contends that proposed rules to implement several of these provisions have been pending at OMB for 8-9 months – a period of review that exceeds the time allotted under Executive Order 12866 (that Order mandates review of regulations by OMB within specified timeframes, and with certain exceptions).  The suit also challenges FDA’s decision to exercise enforcement discretion for certain provisions that are self-executing (e.g., preventive controls), and characterizes that decision as “a complete failure to follow a Congressional mandate.”
Plaintiffs cite the numerous outbreaks that have occurred since the passage of FSMA in support of their allegation that “the agency’s unlawful delay is putting millions of lives at risk from contracting foodborne illness.”  They contend that FDA’s failure to issue the regulations and OMB’s failure to provide timely review “constitutes unlawfully withheld and unreasonably delayed agency action” within the meaning of the Administrative Procedure Act ("APA").  They also contend that FDA’s failure to enforce FSMA’s self-executing provisions constitutes an APA violation.  Plaintiffs ask the court to order FDA to issue the regulations “as soon as reasonably practicable” pursuant to a court-ordered timeline, and to order OMB to approve the regulations and “cease interfering with FDA’s promulgation” of those regulations.  Plaintiffs also ask the court to order FDA to “enforce all self-executing FSMA regulations immediately.”
The filing of this lawsuit comes as little surprise given the constituencies that backed passage of FSMA and the delays in the completion of OMB’s review.  APA litigation to compel agency action is typically protracted, so we expect to follow this case for months (if not years) to come. read more..

source:http://www.fdalawblog.net

Health Care Provider-Consumer Perceptions-Prescription Drug-Federal Register-Dtc Advertising

Drug Ads "Coupons: Who's the Decider? The Patient, the Physician, or the FDA?

The FDA is concerned that the use of sales promotions such as free trial offers, discounts, money-back guarantees, and rebates in direct-to-consumer (DTC) prescription drug ads "artificially enhance consumers' perceptions of the product's quality" while also resulting in an "unbalanced or misleading impression of the product's safety." To test whether or not this is true, the FDA will soon start yet another study focused on Rx print ads: "Effect of Promotional Offers in Direct-to-Consumer Prescription Drug Print Advertisements on Consumer Product Perceptions" (see Federal Register Notice archived here).
[I recently posted about another planned FDA study to determine if disease awareness information in branded ads confuses consumers. See FDA Concerned About Product (eg, Lyrica) Ads That are Too "Educational"]
The history of this study is long and mysterious. I first blogged about it 2006; read "FDA, Coupons, and Sleep Aid DTC Ads." Shortly after that the Federal Register notice regarding the study was "yanked" (see "FDA Backs Down on Coupon Study"). Also, the Advertising Age and Wall Street Journal articles cited in those posts can no longer be found in the archives.
In September, 2011, however, the proposed study re-emerged in the Federal Register (here). Whatever happened between 2006 and 2011 is anybody's guess, but I assume that the Bush era FDA leaders axed the proposed study when they learned of it. By September, 2011, these people were on the way out and the door was open again to propose the study anew.
Anyhoo, I want to focus here on comments that PhRMA made in response to the proposal. Alexander Gaffney (@AlecGaffney), Health wonk and writer of news for @RAPSorg, summarized the general attitude of PhRMA (see "US Regulators Move Ahead With Planned Study on DTC Marketing"):
In its statement to FDA, PhRMA wrote it was “concerned that the study, as currently envisioned, will not yield information that is relevant to FDA’s regulatory responsibilities to ensure that DTC advertising is truthful, accurate and balanced.”
“Although the study may provide interesting information about the effect of promotional offers on consumer attitudes toward a brand,” explained PhRMA, “it likely will provide little information on whether promotional offers create or contribute to false or misleading advertising, particularly under real-world circumstances or whether additional regulatory requirements are warranted.” PhRMA: The Physician is the Decider
I dug a little deeper into PhRMA comments (here) and was surprised to learn that PhRMA's position is that "it is the physician, not the patient (my emphasis), who ultimately must decide whether the benefits of the advertised drug outweigh its risks for any particular patient." Thus, says PhRMA, "the risks of 'misperceptions' ... should be even lower [PhRMA's emphasis] for prescription drugs than for experience goods [i.e., a product or service where product characteristics, such as quality or price are difficult to observe in advance, but these characteristics can be ascertained upon consumption] because any potential misperception, of necessity, will be quickly corrected prior to use through consultation with the patient's treating physician."
This is a very paternalistic POV in this day and age of social media and patient empowerment. Actually, it is the old "learned intermediary" defense that the drug industry often raises (in the past, less so these days) to shield itself from blame when things go wrong.
FDA must respond to comments submitted, but I couldn't find a direct response to PhRMA's comments cited above. I did find, however, the following comments and FDA's response that addressed the issue of the patient-physician relationship generally:
(Comment 22) Two comments mentioned that the study does not assess how consumer perceptions of product risks and benefits are translated into a discussion with their health care provider. read more..

Food Safety Modernization Act-Preventive Controls-Ricardo Carvajal-Provisions-Fsma

It’s Official – FDA States Intention to Exercise Enforcement Discretion for Key FSMA Provisions

By Ricardo Carvajal -In several letters issued to trade associations on June 18th (for an example, see here), FDA stated that it “will expect to enforce compliance” with the preventive controls provision in section 103 of the Food Safety Modernization Act ("FSMA") and the foreign supplier verification provision in FSMA section 301 “in timeframes that will be described in the final rules.”  Given that the proposed rules for those provisions have yet to publish, it is clear that industry will have substantial additional time to come into compliance with the requirements in those provisions.  However, that time will not be unlimited.  If the delay in publication of proposed and final rules proves too protracted, consumer advocates can be expected to put FDA’s feet to the fire. read more..

source:http://www.fdalawblog.net

Fda Inspection Report-Adult Stem Cells-Banking Company-Manufacturing

Serious manufacturing issues found at Celltex facility

An FDA inspection report for Texas stem cell banking company Celltex includes a long list of manufacturing and lab problems, but the company says it is more a problem of language than cGMPs.The 483 report says that during its April inspection at the Sugarland, TX, facility, the FDA discovered a lengthy list of issues, from failing to make sure the treatments produced there are sterile to labeling problems and whether the products contained the viable stem cells they are supposed to, reports in-Pharma Technologist. Inspectors found a bottle whose English-language label indicted it was a manufacturing reagent but it also had a Korean label that indicated it contained a cleaning or sanitizing product.Celltex, which provides adult stem cell banking and multiplication services, previously has been criticized for allegedly providing adult stem cells for illegal use in humans. In March Bioethicist Glenn McGee resigned from his post at stem cell company after just three months. McGee, founder of The American Journal of Bioethics, took flak from his peers in the bioethics community over his taking the position at Celltex while still serving as an editor for the journal.The company issued a statement last week that it has worked "closely with the FDA--both during its visit and since--to provide requested details and documentation to answer its questions," in-Pharma Tecnologist reports. "We have resolved many of the FDA observations, and we are working to address the remainder. We have an open line of communication with the FDA and expect to maintain that in our cooperative relationship."  The company laid many of the problems off to the fact that the lab is run by its licensing partner RNL Bio with technicians and scientists from RNL's Seoul, Korea, headquarters, in-Pharma Technologist says.- read the in-Pharma Technologist story
- here's the the FDA inspection report
Related Article:
Bioethicist quits job at controversial stem cell outfit read more..

source:http://www.fiercepharmamanufacturing.com/

Corporate Integrity Agreement-Manufacturing Processes-Gsk

Settlement unveils fed's leash on Glaxo manufacturing

For the last two years leading up to last week's extensive settlement with U.S. authorities, GlaxoSmithKline ($GSK) already has been operating under an agreement that gives the Office of Inspector General in the Department of Health and Human Services broad authority over its manufacturing processes. The requirements are in addition to any company's usual obligations to the FDA and the agreement lays out a financial price tag if the U.K. company runs afoul of it.The provisions of the agreement are tied to deep problems at GSK's Cidra, Puerto Rico plant, which was closed in 2009. The problems, which included using tainted water in processes and mixing products in packaging, came to light  in the whistleblower lawsuit brought by Cheryl Eckard, a former quality assurance manager with GSK. In October 2010, GSK agreed to pay the government $750 million to settle civil and criminal charges that it manufactured and sold adulterated drug products to Medicaid and other government health plans. The details of the compliance program have now been made public and became Appendix D to the Corporate Integrity Agreement GSK signed as part of its $3 billion settlement announced last week."This is the first time that the government, as part of a Corporate Integrity Agreement, has required a pharma company to establish a formal program to provide ongoing oversight, including Board oversight, of product released to the market to ensure that it is not adulterated," Lesley Ann Skillen, a partner in the law firm of Getnick & Getnick, who settled a related whistleblower case against Glaxo in 2010, says in an email.The oversight program is run through the "Global Manufacturing and Supply business unit" (GMS) and essentially applies to all of its manufacturing operations and employees globally. It is centered at GSK's plant in Zebulon, NC, because employees there "are responsible for the release and post-release management of all Covered Products" manufactured by the company.The program establishes a code of conduct, which employees are schooled in and must sign. It is overseen by a "GMS compliance officer" that can't be the CFO or the General Counsel of the company or subordinate to them. The compliance officer and the president of the GMS unit are the co-chairs of a compliance committee that meets quarterly to make sure the company is meeting all of its obligations. They report at least quarterly to the GSK board of directors. Board members then must sign agreements that are sent to the inspector general that the company is complying with all cGMP requirements or explain why not. The agreement also permits the FDA to complain to the inspector general if the agency believes GSK is not adequately responding to its directives.The Cidra plant was closed in 2009, 7 years after Eckard first complained to her superiors about a host of problems. In an interview last year with CBS 60 Minutes, Eckard said, "All the systems were broken, the facility was broken, the equipment was broken, the processes were broken. It was the worst thing I had run across in my career." She said tainted water was used in manufacturing, production lines were turning out too-potent or not-potent-enough drugs, employees were contaminating products and different medications were packed into the same bottles.In her email, Skillen points out, "When Cheryl Eckard reported her concerns about the Cidra plant to the compliance department in 2003, they covered it up. If GSK were to do that now, it could face exclusion from Medicare and Medicaid under this CIA. That should provide a powerful incentive for GSK to do heed warnings they receive from their own employees. That's why it's an important document for GSK and an object lesson for the industry: ignore whistleblowers at your peril."The GSK agreement may have served as a blueprint for the 5-year consent decree that Ranbaxy Laboratories announced earlier this year to settle manufacturing and data reporting problems found at three o read more..

source:http://www.fiercepharmamanufacturing.com/

Pharmaceutical Industry-Advisory Comments-Dissemination-Storyboards-Shire

Shire Seeks to Maintain YouTube 'Loophole' in FDA's Draft Guidelines for TV Ads

FDA has received several comments from the pharmaceutical industry regarding the agency's "Draft Guidance for Industry Direct-to-Consumer Television Advertisements." In past posts I reviewed comments from PhRMA (the drug industry U.S. trade association) and Sanofi (see here and here). In this post, I report on comments made by Shire (find Shire's comments here).
Shire, like Sanofi, Novo Nordisk and Boehringer Ingelheim (BI), believes that submission of a final recorded version of a TV ad for FDA approval prior to being aired would be "burdensome." Shire specifically cites the optional two-step process FDA suggested; i.e., first submit an annotated storyboard and then a final recorded version of the ad. "This sequential two-submission process would double the time and resource burden on sponsors as well as the Agency," says Shire.
Serial OPDP Review Blues
BI also mentioned the "burden" of a two-step process in its comments to the FDA (find them here). But BI was referring to the need to resubmit a new version of the ad after receiving critical comments from the FDA concerning the first version submitted for review. "BIPI is concerned with the incremental time and cost that would be incurred by sponsors to routinely produce and submit multiple broadcasts for the purpose of OPDP [FDA's Office of Prescription Drug Promotion] pre-dissemination review," says BI. "BIPI is similarly concerned that the repeated submissions of storyboards to capture serial sets of OPDP suggestions (i.e., the submission of modified storyboards for advisory comments following integration of initial advisory comments) would greatly increase the time, if not the cost, of producing DTC broadcast ads." BI says that it "behooves sponsors to ensure storyboards submitted for advisory comments are representative of the final ad and to ensure that the Agency's comments are incorporated into the filmed version." In other words, BI suggests FDA just look at storyboards and trust that the sponsor will create a final "filmed" ad that is revised according to FDA comments.Shire, however, was the only pharma company to point out a "loophole" that I revealed on Pharma Marketing Blog in March (see "A Loophole (?) in New FDA Guidance on Pre-Dissemination Review of TV Direct-to-Consumer Ads"). In that post, I said:
"FDA does not define what exactly it means by 'dissemination.' Perhaps it has defined this term elsewhere in it regulatory archives, but I assume in this case it means airing the ad on mass market TV. Does that include uploading the video to YouTube? A drug company could upload a video of a pre-approved ad to YouTube at the same time that it submits the video to FDA for 'pre-dissemination' review. The video can then be embedded in the drug.com website or promoted via Twitter."Shire pointed out the same lack of clarity in its comments. "...there has been increasing availability and use of vehicles other than broadcast TV to present video advertising, such as on-demand viewing via the Internet," says Shire. "Shire recommends that FDA affirm that the scope of the guidance includes only DTC advertisements disseminated through broadcast television."
FDA and the drug industry continue to see no need to issue any mandatory or even voluntary guidelines specifically for drug promotion via the Internet. Shire points out, for example, that there already is an "advisory review process" that applies to video advertisements disseminated through "other viewing platforms' (i.e., the Internet). That process (see here) says "a sponsor may voluntarily submit advertisements to FDA for comment prior to publication."
However, if "dissemination" is defined according to Shire's rules, then it is possible for a drug company to run a video ad on YouTube months before it airs the same ad on TV without having to submit anything to the FDA for review -- the current "advisory review process" that Shire refers to is voluntary.
As part of that process (e.g., su read more..

Kv Pharmaceuticals-Compounders-Makena-FDA

FDA keeps door open to cheap versions of KV's Makena

The battle over KV Pharmaceuticals' ($KV.A) pricey preterm-labor drug, Makena, with pharmacy compounders who can make it for next to nothing has hit a new phase. The FDA this week announced it found no major safety problems with compounded versions of Makena. Then KV released a statement emphasizing another part of the FDA's announcement--that agency-approved drugs provide greater assurance of safety and efficacy. After getting approval for its drug, KV began charging $1,500 a dose, while previously women were able to buy it for about $20 a dose from compounders. In the outcry, KV lowered the price to $690 but the FDA allowed the compounded versions to remain on the market. Then KV asked the FDA to investigate whether they were safe and consistent. The FDA this week said it found that all of the APIs met standards for potency and total purity. When compared with Makena's NDA standards, a few of the samples fell short on some measures. And so the fight continues. Story | More read more..

source:http://www.fiercepharmamanufacturing.com/

Federal Authorities-Prescription Drugs-Internet Pharmacy-Canadian Internet-Counterfeit Drugs

Canadian Internet pharmacy leader faces federal charges

The founder of a Canadian Internet pharmacy accused of selling counterfeit drugs will be arraigned this week in federal court, putting other operators around the world on notice that the U.S. is stepping up enforcement on that loose link in the supply chain in which thousands of Internet sites sell drugs of unknown origin to people without prescriptions.The 38-year-old Andrew Strempler, who was arrested last week, was a pioneer in this arena. In an indictment he and his former company RxNorth.com are accused of selling and shipping to U.S. consumers fake and misbranded drugs between early 2005 and the summer of 2006, The Wall Street Journal reports. Strempler sold his company to a competitor in 2006, and was believed to have hightailed it to the Caribbean after U.S. authorities accused him of selling counterfeit medications. Authorities globally have been trying to figure out how to attack the growing problem of counterfeit drugs making their way to consumers through this unregulated end-run around the legitimate supply chain.The arrest follows an FDA warning in May that fake versions of the ADHD drug Adderall, made by Teva Pharmaceutical Industries ($TEVA) and other generics companies, is showing up on Internet pharmacy sites. At least some of the counterfeit Avastin discovered in the U.S. in February squeezed its way in through a Canadian pharmacy company that delivers discounted prescription drugs from overseas to U.S. citizens.The owner of one Canadian Internet pharmacy acknowledged shipping at least some of the fake injectables of the Roche ($RHHBY) drug into the U.S. but said he notified authorities when he learned they were counterfeit.In a report in March 2011, the Counterfeit Pharmaceutical Inter-Agency Working Group, made up of a host of federal agencies and authorities, acknowledged the growing threat and said it was looking for ways to be proactive to a threat that is global in nature and difficult to monitor.  In a recent interview, Connie Jung with the FDA explained that illegal Internet pharmacies presented a particular challenge to federal authorities because they may sell counterfeit or other unapproved drugs. Jung is the acting associate director for policy and communications within the Office of Drug Security, Integrity and Recalls. It was established last year to focus on such problems as drug counterfeiting in an industry that now relies on a global supply chain. Part of its work is to coordinate with other agencies like Customs and the FBI to find ways to be proactive in the face of a serious threat."Consumers and healthcare providers can be confident that consumers are receiving safe, effective, high quality drugs from their local pharmacies," Jung says. "It is when we have entities that choose to buy outside the legitimate drug supply chain that harmful products may be introduced." The U.S. is not alone in trying to figure out how to get on top of this new outlet for counterfeits. China Daily reports that after a 5-month investigation into counterfeiting there, the State Food and Drug Administration sent 670 cases to the police for investigation. "Many counterfeit drug cases featured online advertisements and sales, underground production workshops and transfers through postal express," Yin Li of the SFDA says.- read The Wall Street Journal story
- get the China Daily storyRelated Articles:
Fake of Roche's Avastin shipped from Canadian supplier
Adderall shortage spurs counterfeiters to step in, FDA says
FDA warns 56 more docs of fake Avastin supplies
FDA commish suggests putting more bite in laws for counterfeiting
Fake Adderall surfaces as Congress turns attention to track and trace read more..

source:http://www.fiercepharmamanufacturing.com/

Prescription Drug User Fee Act-Drug Approval Process-Medical Device-Congress-FDA

Bipartisanship in Congress, in Support of Pharma and Device Industries

It's often said today that Congress is totally dysfunctional and cannot agree on anything due to the huge partisan culture war. Well, the good news is that there's bipartisan cooperation on at least one issue. The bad news is that it's all in favor of handing the foxes at the pharmaceutical and medical device industries the key to the FDA henhouse. 
The estimable Merrill Goozner: http://gooznews.com/?p=3914--has blogged about the latest renewal round of the Prescription Drug User Fee Act, where drug firms agree to pay a lot of the freight for running the FDA's drug approval process, and almost always manage to wring out favorable concessions in exchange for their largesse. Among the Christmas list the industry wants this time, and that Congress, well primed by the lobbyists, is apparently ready to hand them, are:

• More use of surrogate markers to approve new drugs, without demanding proof that the actual diseases that affect people get any better (e.g., a drug that lowers blood sugar but does nothing to prevent heart attacks or strokes or blindness from diabetes)
• Complete gutting of the reforms called for in the recent Institute of Medicine report to toughen requirements for testing new devices for safety

Gooz reports that consumer advocacy groups are incensed over these concessions but are getting nowhere with Congress.
The solution, as we have known for a good while, is to stop depending on the drug industry to fund the FDA--though replacing drug bucks with taxpayer bucks won't make that army of lobbyists go away (meaning that at some point or other, campaign finance reform is desperately needed as well). read more..

Fda Mobile Regulatory Fear Mongering-Phrma-FDA

FDA Mobile Regulatory Fear Mongering by PhRMA

In a blog post provocatively titled "An App for That, But For How Much Longer?" (here), PhRMA's Kate Connors agreed with a Washington Times op-ed piece that suggested the FDA will soon require apps such as medication prescription renewal reminders and blood glucose level tracking functions to be regulated as medical devices. You can read the op-ed in this threaded archive: "How safe is that app? Should pharma apps be registered as medical devices?".
The op-ed author, Joel White, executive director of the Health IT Now Coalition, "suggests that this effort would lead to increased costs as well as constraints on user access to these apps, which 'may cause developers to move on to other, less burdensome endeavors.' In the end, this could hinder the way that patients can actively improve their own care," said Conners.
Before I get to destroying the case made by Connors and White, I should point out how these two people are related. White is the president of JC White Consulting, a registered lobbying firm (see here) retained by the Health IT Now Coalition and PhRMA, among others (see here). In her blog post, Connors said "A few days ago, I missed an op-ed in the Washington Times that I just came across today – and I’m glad I did." Joel, you should have DM'd Kate! Whatever! It's nice that White gets paid to write this "independent" op-ed piece that PhRMA can cite as if it were independent! Guys! Wake up! It's the era of transparency! Unfortunately, you can fool some -- maybe even most -- of the people all of the time and that is what keeps PhRMA in business.
Anyway, back to "FDA Mobile Regulatory Fear Mongering." I say "fear mongering" because it can't be true that White and Connors failed to read FDA's July guidance in which it stated that the agency does NOT consider the following types of apps to be mobile medical apps for purposes of the guidance:
"Mobile apps that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness. Such decisions, suggestions, or recommendations are not intended for curing, treating, seeking treatment for mitigating, or diagnosing a specific disease, disorder, patient state, or any specific, identifiable health condition. Examples of these apps include dietary tracking logs, appointment reminders, dietary suggestions based on a calorie counter, posture suggestions, exercise suggestions, or similar decision tools that generally relate to a healthy lifestyle and wellness."PhRMA/White do not quote FDA because to do so -- as I just did -- would kill the argument that FDA mobile guideline/regulations will stymie pharma from developing apps and will "hinder the way that patients can actively improve their own care." You should also read "No, the FDA is not assaulting mobile technology, Washington Times editorial misguided" published by iMedicalApps.
Meanwhile, there are medical apps being created by pharma that SHOULD be regulated by the FDA, IMHO. These are "calculator" apps designed to be used by physicians during diagnoses. One such app had to be "recalled" because of a bug that generated incorrect results. Unfortunately, thousands of physicians may not have heard of the "recall," which merely removed the app from app stores, not from the phones of physicians who downloaded the app. These physicians may still be using the buggy app. See "The Problem with Unregulated 'Calculator' Apps for Physicians: Buggy Software!"
P.S. Connors pointed out that PhRMA has its own medication reminder app for patients: "In fact, we at PhRMA have helped support the Script Your Future campaign, which itself includes medication reminders as a tool."
Just for fun, I signed up to receive reminders. I was, however, somewhat put off by the long legal disclaimer, which said, in part:
"You acknowledge and agree that we provide the reminder service and access to the reminder service as an "as is" and an "as read more..

Pharmaceutical Industry-Supply Chain Security-Purdue Pharma-Cargo Theft

Here are some tips on cargo theft that might save you $75M

As I was reading the FDA's new SOP on cargo theft this week, I was reminded  of a conversation with Charles Forsaith, director of supply chain security for Purdue Pharma Technologies. He also coordinates the Pharmaceutical Cargo Security Coalition, which is dedicated to combating theft of pharmaceuticals in transit.Our talk centered on how U.S. manufacturers in the last couple of years have made a giant leap forward in protecting against cargo theft. He pointed out that last year there were only 5 stolen shipments valued over $500,000 and only three over $1 million, compared to 15 and 11 in 2009. That calculates to 33% and 25% decreases in just two years. Forsaith explained those results have been hard-won.Just a few years ago, the industry was losing loads that had values rivaling the numbers normally associated with the salaries of professional athletes.There was the dramatic burglary of and Eli Lilly warehouse where rope-rappelling thieves stole cancer, cardiovascular and depression medications. Loss: $75 million.There was a similar burglary at a GlaxoSmithKline warehouse. Loss: $6 million.And there was a 2009 heist of a rig from North Carolina, containing Novo Nordisk ($NVO) drugs, some of which later were tied to adverse reactions from patients who got them from a pharmacy chain. Loss: $10.9 million. It hasn't been that many years, Forsaith said, since drivers would arrive at a shipping dock and the only thing anyone was concerned about was whether they made it to where they were going by a particular point in time. "You didn't necessarily collect the name of the driver, get his cell number, make or a description of the truck, put a high-security cargo seal on the back door, tell the driver that he was not supposed to stop for so many miles. There were so many things that we took for granted."But with losses, and attendant publicity, growing changes were made. The coalition was formed, information was shared and companies were educated. The pharma industry learned from the practices, and the mistakes, of others such as manufacturers of high-end electronics and jewelry.Now companies vet their shippers to make sure they use two drivers and never leave a rig unoccupied. They paint trailers with large letters to make them easy for law enforcement to spot if they are taken. They use technology, like planting GPS devices in a load, or even use trailers with doors that close with a magnetic lock initiated by a cell phone and not even accessible by drivers. They constantly share information so danger spots for truck heists are quickly identified and can be avoided. This has all made loads harder to steal and easier to recover if they are taken.At the warehouse level, guards, lights and fencing can all make a difference, but Forsaith says he also urges warehouse operators to get to know their business neighbors and share contact numbers in case someone sees something unusual on a weekend, holiday or after hours. "It is just like a neighborhood watch, but just on a much grander scale."The world remains a dangerous place, Forsaith acknowledges. In other countries gangs often use weapons and violence to steal pharmaceuticals. But at least in the U.S., the situation is so much better.In fact, FreightWatch International reported last year was the first time on record in which the "pharmaceutical industry did not have the highest value per theft incident." That honor went to the electronics industry. -- Eric Palmer (Email | Twitter) read more..

source:http://www.fiercepharmamanufacturing.com/

Supplemental Application-Hypercholesterolemia-Phase Iii Trial-Pink Sheet-Fda Panel

Coming In Thursday's 'The Pink Sheet' DAILY - FDA User Fee Bill Moves Through House

House is expected to pass FDA user fee bill - Regeneron and Sanofi plan to begin a Phase III trial of their PCSK9 inhibitor for hypercholesterolemia - FDA panel to review GlaxoSmithKline's supplemental application for use of Tykerb in combination with Herceptin in women who failed on Herceptin alone read more..

source:http://www.biopharmatoday.com

Prescription Drug-Medical Providers-Alert Systems-Fda Drug

FDA fails to send alerts on 20% of Class I drug recalls

The FDA hasn't always been on top of notifications to medical providers about the most serious drug recalls, a study has found. Between 2004 and 2011, nearly 20% of the Class I drugs recalls were not included in either of the agency's two alert systems, reports Reuters. Class I drugs include those that can cause "serious adverse health consequences or death." Over the 8 years, Joshua Gagne of Brigham and Women's Hospital in Boston and other researchers counted more than 1,700 FDA drug recalls and found only 91 were serious Class I recalls. The agency sent out 2,900 announcements through the Recall Alert System but included alerts for just 55 of the 91 Class I recalls. Its MedWatch system picked up another 18 of the remaining recalls, but 18 more, or 20% of the Class I recalls, were not reported through either system, the study found. The researchers acknowledge they couldn't document any adverse effects related to the failure and also that FDA has made strides in the last year. They suggest, however, that the agency set up a system specific to Class I drugs. The problem of recalls is complex. A recent report found that last year there were 55 prescription drug recalls and 14 recalls related to OTC products, but the OTC recalls involved millions more products. Story | More read more..

source:http://www.fiercepharmamanufacturing.com/

Health Connections-Corporate Blog-Search Result-Breast Cancer-Drug Product

AZ Posts 'Reminder Drug Ad' to Its Corporate Blog

Last week I reported that AstraZeneca (AZ) posted an ad for CRESTOR on its "AZ Health Connections" corporate blog (see "AstraZeneca's Timely CRESTOR Branded Blog Post: Did It Violate Its Own Policy?"). The post included the indication for CRESTOR and also the "Important Safety Information" (ISI) that is required by the FDA whenever a drug company talks about a brand and its approved indication.
I wrote about that only because it was the first time -- to my knowledge -- that a pharma corporate blog promoted a branded product and I wondered if such posts violated AZ's own posting policies (turns out that it may or may not depending upon what you mean by "may" -- see the post for details).
Today, I noticed an AZ Health Connections blog post that talked about another AZ drug - ARIMIDEX, which is approved for "adjuvant treatment (treatment following surgery with or without radiation) of postmenopausal women with hormone receptor-positive early breast cancer."
This time, however, the post (find it here; see screen capture above) did NOT mention the approved indication. It is, by FDA definition, a "reminder ad." According to the Pharma Marketing Network Glossary:
Reminder advertisements are identified as an exemption to the advertisement regulations, including provisions to provide a brief summary. Reminder advertisements " . . . call attention to the name of the drug product but do not include indications or dosage recommendations for use of the drug product. . . . and, optionally, information . . . containing no representation or suggestion relating to the advertised drug product." Reminder advertisements cannot make a representation about the product or suggest a use for the product.The AZ Health Connections post does "call attention to the name of the drug," but it also directs readers to ARIMIDEX Direct, which is a program that "allows eligible patients to receive ARIMIDEX delivered to their homes for $40 a month, including shipping and handling." Sounds like a good deal, although I did not investigate what the eligibility requirements were.
AZ deserves credit for reaching out to the online community to learn more about how it can make its drugs more accessible. Recall that AZ was the first pharma company to host a Twitter chat "to raise awareness about helping patients save money through prescription savings programs" (see "OMG! AstraZeneca Hosts Twitter Chat & World Does NOT End!").
PhRMA "forbids" Reminder Ads, But Not on Internet!
AZ's post raises some interesting questions regarding the promotion of Rx drugs on the Internet that neither the FDA nor the pharma industry has addressed. For example, PhRMA's "Guiding Principles for Direct-to-Consumer Advertising" (here) prohibit reminder ads on TV but NOT on the Internet:
Principle #10: "DTC television advertising that identifies a product by name should clearly state the health conditions for which the medicine is approved and the major risks associated with the medicine being advertised." [Alos see "Reminder Ads - Pharma's Dodo?"]AZ, I believe, is a signatory to these voluntary guidelines. Since these guidelines only apply to TV advertising, AZ is not in violation. It's still the "wild west" on the Internet with regard to reminder ads; i.e., It's perfectly fine to run "reminder ads" on the Internet. This is usually the case when pharma companies buy Adwords (paid search ads) from Google, especially after the FDA came down on Adwords that included the indication with the brand name.
Another interesting issue is how pharma companies can manipulate "natural" (aka "organic") Google search results to display what is essentially a branded product ad that includes the brand name and indication, but no ISI.
Search Google for "arimidex" as I just did and you will find this:
The #4 (or #3, depending on how you count) search result leads you to the home page of the www.arimidex.com Web site. Note that the search result looks like an read more..

Counterfeit Drugs-Fda Commissioner-Track And Trace-Cancer Drug

FDA, industry differ on level of track and trace needed in U.S.

Drug manufacturers may have derailed the FDA's plan to force creation of a vial-specific tracking plan to combat counterfeit drugs.The plan is facing resistance from companies like Pfizer ($PFE) and Merck ($MRK), as well as from pharmacies and distributors. It is estimated it would cost pharmacies $6 billion to put their piece in place.The industry is backing a plan that tracks lots instead of individual containers. They say it could be refined later to track smaller quantities. The plan put up by an industry coalition would put unique serial numbers on individual drug packages, but require scanning drugs only in "lots" when they get to distributors."Often in crafting policy, there's the search for the perfect and we just walk by the good," Pfizer spokesman Peter O'Toole told Reuters. "We could be saying in 10 years, 'we have to work on something perfect.' And in the intervening years, we would have done nothing, and that would be a shame for patients."The discovery of fake versions of Roche's ($RHHBY) cancer drug Avastin throughout the U.S. in recent weeks has added to the urgency to create a program."To learn that the cancer drug you were taking to save or prolong your life might be nothing but a counterfeit is unthinkable," FDA Commissioner Margaret Hamburg recently wrote on the agency's blog. "We ... need authority to require a robust system to track and trace all drugs throughout the supply chain."The discussion of how to trace individual containers has been going on for a long time, but no one wants to foot the bills. The experience of California is an indication of how difficult it has been to get the industry's support. It passed a track and trace law in 2004, but opponents have repeatedly delayed implementation. It is now set to go online in 2015.The FDA and the industry are both seeking to have the outlines of a plan included in FDA user fee legislation now before Congress, but which plan, if any, makes it in is still up in the air.- here's the Reuters storyRelated Articles:
FDA warns 56 more docs of fake Avastin supplies
Fake Avastin case highlights need for supply-chain controls read more..

source:http://www.fiercepharmamanufacturing.com/

Prescription Drug-Fda Regulations-Public Hearing-Social Media-FDA

A Cautionary Tale for Anyone Expecting FDA Social Media Guidelines Any Time Soon

If you think waiting over two years for FDA to issue guidelines it promised for regulation of "Promotion of Prescription Drug Products Using Social Media Tools," then you should take a look at the following timeline and weep.
This timeline documents the major steps in FDA's process of developing guidance for direct to consumer television (DTC) and radio ads; ie, "standards that would be considered in determining whether the major statement in direct-to-consumer television and radio advertisements relating to the side effects and contraindications of an advertised prescription drug intended for use by humans is presented in a clear, conspicuous, and neutral manner":

• 1 November 2005: FDA convenes a 2-day public hearing to discuss the issue (see "FDA DTC Hearings: Snippets from Day 1" and "DTC Pros and Cons Presented at Public Hearing"). Sound familiar?


• 21 August 2007: FDA announces it will conduct a study of "consumer evaluations of variations in communicating risk information in direct-to-consumer (DTC) prescription drug broadcast advertisements." It opens a 90-day period to submit comments regarding this study. This study used the latest cognitive science technique called Affect Misattribution Procedure (AMP), in which participants are asked not to judge the TV ads' imagery directly, but to judge whether or not a Chinese character shown to them afterward is positive or negative. I suggested it NOT use Chinese characters because that would be discriminatory, but they did not listen to me (see "FDA at a Mall Near You: The Manchurian Connection"). With regard to social media guidelines, the FDA has also announced it will do some studies before issuing guidance (see "FDA's Proposed Web Study Will Further Delay Social Media Guidelines"). Deja vu all over again!


• 29 March 2010: FDA finally publishes the draft guidance, more than 4 years after the public hearing (see Federal register ref: 75 FR 15376). FDA was goosed along by an act of Congress: the Food and Drug Administration Amendments Act of 2007 (FDAAA), which required that the major statement in DTC television or radio advertisements (or ads) relating to the side effects and contraindications of an advertised prescription drug intended for use by humans be presented in a clear, conspicuous, and neutral manner. FDA was forced into RULEMAKING mode rather than GUIDANCE mode, which is how the pharma industry wants the agency to approach the regulation social media drug promotion as well (see "Pfizer Asks for New FDA Regulations, Not Guidance, for Social Media").


• June 2011: FDA published an executive summary of a study of the methodology of the AMP study cited above entitled "A Supplementary Test of Distraction in DTC Advertising Using an Implicit Measure, The Affect Misattribution Procedure" (find it here). Maybe FDA read my comments after all!


• 27 January 2012: FDA announced that it added a document to the docket for the proposed rulemaking concerning a study entitled: "Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Television Advertisements" (Distraction Study; see Docket No. FDA–2009–N–0582). This document reopened the comment period (extending the deadline to February 27, 2012) for the rulemaking proceeding to allow an opportunity for comment on the study as it relates to the proposed standards. Way back during the public hearing in 2005 I was unimpressed by research claiming that TV drug ads were designed to "distract" viewers from reading the fair balance (see op cit and "Ruth Day and the Bees Repeat Performance at House DTC Hearing" for an update on that).


• 23 March 2012: FDA reopens the comment period for a second time "in response to a request for more time to submit comments to the Agency." The new comment period will expire on April 9, 2012. According to the FDA, the "Pharmaceut read more..

Social Media Marketing-Panel Discussions-Pharma Industry-Mobile Search

Musings from DTC National 2011

Didn’t attend DTC Perspectives’ big DTC National conference in Boston this year?
No worries. I spent three days there last week (my first time). Several of us tweeted the highlights using hashtag #DTCN2011, so you can view all the tweets by searching the hashtag on Twitter. You can still view the conference agenda online.
I tweeted. A lot. But one can only say so much in 140 characters or less. So beyond the tweets, I wanted to provide a more in-depth review. Below is the first in a series of blog posts with key observations by day:
DTC National: Day One
Day one of the conference kicked off with a small pre-conference workshop in the morning. Pharma folks gathered for a series of small panel discussions, moderated by Bob Ehrlich, on the following topics:
- Optimizing The Brand Web Site
- The Use of Search
- Advertising on the Web/mobile
- Direct Mail and Direct Response
I was surprised there wasn’t a social media panel, but perhaps everyone’s sick of talking about that for now. How much more can we say about FDA still not delivering guidance anyway?
The panels were lively and informative, focusing in depth on these areas more than – as I learned in later days – the main conference itself. The audience asked questions and there were healthy discussions. I always like the smaller group settings better at these things. A few highlights:
• I laughed during the “Optimizing the Brand Web Site” session when conference chairman and moderator Bob Ehrlich asked the panel to stop talking about mobile (because there was a separate upcoming panel on mobile). What was left unsaid was that the Web and mobile are so intertwined that the two cannot be separated. I saw a tweet last week rom the iStrategy conference (source unknown) that over 50% of Web activity occurs on a mobile device! But wait … I’m not supposed to be talking about mobile here … so moving on …
• I spoke on the panel on which I thought was going to be about online and mobile media – “Advertising on the Web/mobile” - but which turned out to be all about mobile. We talked about optimizing sites and the plethora of healthcare apps available today. And we all agreed that there is a lot more for pharma to be doing in this channel. It struck me, too, that there’s so much more to mobile than just apps or mobile sites … there’s mobile media, mobile search, and optimizing emails for mobile viewing. At what point will pharma pay attention to these on a regular basis? I fear we’re a long ways off.
• I particularly enjoyed the “Use of Search” panel where Yahoo!, Google, and Bing representatives (among others) all gathered to discuss character limitations and potential implications of coming DDMAC guidance. To their credit, they were certainly mindful of the issues the industry faces. And the question was asked … who says there have to be character limitations? Not FDA .... Google, Yahoo! and Bing decide! I was pleased to see so many search reps at the conference and their industry’s openness to working with the pharma industry's – shall we call them – "special circumstances."
• The multicultural panel was hosted by several multicultural marketing agencies who made the very valid case for pharma to be reaching out to minorities, especially in relevant conditions such as diabetes and hypertension that disproportionally affect African-Americans and Hispanics. I have the hunch multicultural marketing is to pharma now as social media marketing was to pharma a few years ago: Marketers have an inkling they need to be doing it, but they don’t know much about it so they avoid it altogether.
While Bob’s panel moderation style came across a bit condescending - as if he didn’t believe people went on the Web or used mobile phones to do anything but talk - it also provided healthy perspective. We in the marketing and digital worlds drink our own Kool-Aid every day. Bob’s right – some of the consumers we’re trying to reach are read more..

source:http://intouchsol.com

The Government Accountability Office-Regulatory Compliance Services-Outdated Technology

GAO hammers FDA for not updating IT system, using faulty system to track foreign drugmakers

The FDA will continue to rely on an outdated technology system for tracking foreign drugmakers while it continues to implement a new IT system it started on a decade ago. A report issued recently by the Government Accountability Office (GAO) says the agency has significant work left to do before it implements all of its Mission Accomplishments and Regulatory Compliance Services (MARCS) system. Until that is up and running--perhaps in 2014 if a lot gets done in the next two years--it will continue to use it OASIS system, which the GAO twice has criticized for not being able to provide accurate reporting of drug manufacturers outside of the U.S., inPharma Technologist reports. FierceGovernmentIT points out that part of the problem is that FDA has no unified, long-term IT strategy because it's had 5 chief information officers in the last four years. Story | More from FierceGovernmentIT read more..

source:http://www.fiercepharmamanufacturing.com/

Ethylene Glycol-Fda Inspectors-Hospira-Csl

CSL recalling product tainted with ethylene glycol

Two companies that have fallen under the shadow of FDA inspectors in the last year initiated product recalls this week. CSL Biotherapies ($CSL.AX) is recalling 6 batches of Albumex after tests showed some of it is contaminated with low levels of ethylene glycol. In a separate incident, Hospira ($HSP) is recalling syringes because some were believed overfilled.The Australian Therapeutic Goods Administration (TGA) in March quarantined 96 batches of the CSL product to investigate ethylene glycol contamination. The organic compound, which is commonly associated with antifreeze, has medical uses. It can cause poisoning in high enough doses.In an announcement Wednesday, the TGA says of those 96, 18 batches have low levels of ethylene glycol. Most of those have already been quarantined at hospitals or warehouses, but 5 that had already been exported are being recalled.Hospira began a recall of one lot of morphine sulphate injection after a customer reported discovering syringes containing more than 1 ml. Hospira distributed the lot, each box of which contains 10 prefilled cartridges, to "a limited number of hospitals" in 10 states, in-Pharma Technologist reports. The FDA alert says the affected lot was distributed in January but that Hospira has not received any reports of adverse events related to the problem.Both companies have had run-ins with the FDA over lapses in their manufacturing quality. Flu vaccine maker CSL was cited by the FDA in June for a lack of follow-through on raw material test failures to half-hearted investigations into adverse reactions suffered by hundreds of Australian children after they received the Fluvax shot last year. Twenty-three of those children landed in the hospital with seizures and fever. The Australian government ultimately withdrew the flu vaccine for use in children.The company has been working through manufacturing issues at plants in Austin, TX, and Rocky Mount, NC. The North Carolina facility was closed in December after quality issues were raised by the FDA but resumed production in January after the company threw extensive resources at fixing problems. It expects the plant to hit 60% to 70% production capacity by year's end.The company has been adding a slew of new people to its manufacturing and quality control ranks. Just this week it named industry veteran John B. Elliott senior vice president of operations. He will have responsibility for Hospira's global operations organization.- here's the in-Pharma Technologist story
- get the TGA announcement
- read the FDA alertRelated Articles:
Vax maker CSL hit with FDA warning
Hospira taps drug industry veteran to oversee operations
Hospira sees dim light at end of plant troubles read more..

source:http://www.fiercepharmamanufacturing.com/