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..
Thursday, 21 June 2012
Federal Authorities-Prescription Drugs-Internet Pharmacy-Canadian Internet-Counterfeit Drugs
Friday, 18 May 2012
Prescription Drugs-Heart Disease-Heart Attack-Percentage
The percentage of the U.S. population taking at least one prescription drug during the past 30 days increased from 38% in 1988–1994 to 48% in 2005–2008. During the same period, the percentage taking three or more prescription drugs nearly doubled, from 11% to 21%, and the percentage taking five or more drugs increased from 4% to 11%. These data come from the CDC "Health, Unites States, 2011" report (find it here).
Meanwhile, the prevalence of heart disease, which is the leading cause of death in the U.S., remained steady from 1999–2000 to 2009–2010 among adult women in all age groups, and among men 45–74 years of age. Among men 75 years of age and over, prevalence rose from 39% in 1999–2000 to 45% in 2009–2010.
There goes my rationale for taking statins to lower my risk of heart attack! It seems that the drug industry is not as successful in improving our health as it claims to be.
And new drugs aimed at lowering the risk for heart disease currently being developed may be effective in achieving "surrogate endpoints" in clinical trials but not effective in reducing risk.
That was the takeaway from a new study published online recently in The Lancet. That study provided evidence that increasing the level of HDL ("good cholesterol") does not lead to less risk for heart disease (see "HDL hypothesis is on the ropes right now").
That's not good news for companies that are actively developing and testing drugs that raise HDL -- even if these drugs succeed in that goal they are not likely to help prevent heart disease.
There's lots of other interesting data in the CDC report. I've gathered my favorite charts into the infographic shown here (click here for an enlarged view). read more..
Wednesday, 21 March 2012
Food And Drug Administration-Television Advertisement-Prescription Drugs-Warning Letter
On September 27, 2007, President Bush signed into law the Food and Drug Administration Amendments Act of 2007 (FDAAA), which gives FDA the authority to ". . . require the submission of any television advertisement for a drug . . . not later than 45 days before dissemination of the television advertisement." The notice of issuance of "Draft Guidance for Industry Direct-to-Consumer Television Advertisements — FDAAA DTC Television Ad Pre-Dissemination Review Program" was published today in the Federal register (see "Draft FDA Guidance on PreDissemination Review of TV Direct-to-Consumer Ads").
Before I get to the "loophole," here's a summary of the guidance.
Up until now, the FDA allowed the VOLUNTARY submission of TV ads for review prior to airing, but did not require it. The draft guidance details which type of TV ads REQUIRE approval prior to "dissemination," how long it will take FDA to review these ads and get back to the sponsor (45 days), and what the sponsor can do if the FDA does NOT meet the 45-day deadline. Of course, it also mentions CRIMINAL and CIVIL MONETARY penalties that may be sought by the FDA for violations.
Which Ads Will Require "Pre-dissemination" Review?
The Agency intends to require sponsors to submit TV ads for pre-dissemination review in the following categories:
- Category 1: The initial TV ad for any prescription drug or the initial TV ad for a new or expanded approved indication for any prescription drug
- Category 2: All TV ads for prescription drugs subject to a Risk Evaluation and Mitigation Strategy (REMS) with elements to assure safe use (see section 505-1(f) of the FD&C Act)
- Category 3: All TV ads for Schedule II controlled substances
- Category 4: The first TV ad for a prescription drug following a safety labeling update that affects the Boxed Warning, Contraindications, or Warnings & Precautions section of its labeling
- Category 5: The first TV ad for a prescription drug following the receipt by the sponsor of an enforcement letter (i.e. a Warning or untitled letter) for that product that either cites a TV ad or causes a TV ad to be discontinued because the TV ad contained violations similar to the ones cited in the enforcement letter
- Category 6: Any TV ad that is otherwise identified by FDA as subject to the pre-dissemination review provision
Regarding the 45-Day Review Period, FDA says:
"Once the 45-day review time has elapsed, there is no specific legal consequence resulting from disseminating the proposed TV ad without waiting for FDA’s comments. However, once an ad is disseminated, the sponsor is at risk of enforcement action if the ad violates the FD&C Act and implementing FDA regulations."
That is, if the FDA misses its deadline, the situation reverts back to what is the current practice -- air the commercial and perhaps suffer the consequences, which could be nothing more than a warning letter, but may also require the sponsor to air a correction.
What Exactly Will the FDA Review?
In the past, FDA has primarily reviewed TV Ad storyboards, which are graphical representations of key scenes in the ad with dialog included. Storyboards are blueprints for production and are created BEFORE any video production has begun. Now, however, FDA requires a video of the TV ad to be submitted to fulfill the submission requirements. Only after the video is submitted will the 45-day review clock start running.
"FDA cannot provide final comments on the acceptability of a TV ad without viewing a final recorded version in its entirety. FDA understands that some sponsors may wish to receive comments from the Agency before producing a final recorded version of the ad. In such situations, sponsors can submit a pre-dissemination review packag read more..
Thursday, 15 March 2012
Pharmaceutical Manufacturing-Pharmaceutical Companies-President Barack Obama-Republican Candidates
Pharmaceutical Manufacturing
Pharmaceutical companies, which develop both over-the-counter and prescription drugs, have been among the biggest political spenders for years. While the industry has traditionally supported Republican candidates, some key players have recently increased donations to Democratic candidates as the GOP’s power in Washington erodes. The pharmaceutical manufacturing industry will likely fair better this decade now that President Barack Obama’s initial plan to institute a public health insurance did not become a part of sweeping health care reform legislation signed into law in 2010. A government-run plan, because of its size, would have had considerable negotiating power to draw down drug prices. [Read more Background]Top Contributors, 2011-2012
ContributorAmountPfizer Inc $702,391Amgen Inc $574,648AstraZeneca PLC $527,501Abbott Laboratories $406,773Merck & Co $363,041GlaxoSmithKline $325,741Eli Lilly & Co $264,762Novartis AG $205,209Bayer Corp $124,650Endo Pharmaceuticals $116,400Perrigo Co $111,475Mutual Pharmaceutical $105,000Allergan Inc $88,000Teva Pharmaceuticals USA $86,870Sanofi-Aventis $78,300Bristol-Myers Squibb $70,050Pharmaceutical Rsrch & Mfrs of America $65,450Nostrum Pharmaceuticals $62,300Cephalon Inc $61,250Takeda Pharmaceuticals North America $61,250...view more ContributorsContribution Trends, 1990-2010
...view TotalsLobbying Totals, 1998-2010
...view more LobbyingParty Split, 1990-2010
Top Recipients, 2011-2012
CandidateOfficeAmountObama, Barack (D) $129,139Romney, Mitt (R) $89,300Upton, Fred (R-MI)House $77,575Brown, Scott P (R-MA)Senate $76,483Hatch, Orrin G (R-UT)Senate $69,400...view more RecipientsAverage Contributions to Members of Congress, 1990-2010
...view more Money to Congress Data for the current election cycle were released by the Federal Election Commission on Monday, February 13, 2012 Feel free to distribute or cite this material, but please credit the Center for Responsive Politics. via opensecrets.org Posted via email from Jack's posterous read more..Monday, 12 March 2012
Drug Enforcement Administration-Temporary Restraining Order-Prescription Drugs-Cardinal Health
Does the Drug Enforcement Administration (DEA) understand the distribution system for legitimate, prescription drugs? It sure doesn't look that way. The DEA once again went after Cardinal Health (NYSE:CAH) by suspending the company’s controlled substances license at its Lakeland, FL, facility. Late Friday, Cardinal successfully won a temporary restraining order against the DEA. See Cardinal Health’s statement. Kudos to Cardinal Health CEO George Barrett for standing up to an overzealous DEA. When this happened in 2007, Cardinal’s tentative and indecisive response led to major business losses, from which the company has never fully recovered. I'm curious to see how CVS Caremark (NYSE:CVS) reacts to last Friday's raid at 2 of its Florida stores.As I explain below, the DEA started targeting wholesalers and manufacturers because they can't stop the real criminals—the patients abusing prescription drugs, the physicians running “pill mills,” and the pharmacies dealing these drugs. And don’t even get me started on how the DEA has created a shortage of ADHD meds by putting manufacturers under their thumb…Read more »Copyright © 2006-2012 Pembroke Consulting, Inc. and Copyright © 2006-2012 Drug Channels. This Feed is for personal non-commercial use only. read more..