FDA has received several comments from the pharmaceutical industry regarding the agency's "Draft Guidance for Industry Direct-to-Consumer Television Advertisements."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..
Tuesday, 26 June 2012
Pharmaceutical Industry-Advisory Comments-Dissemination-Storyboards-Shire
Tuesday, 12 June 2012
Pharmaceutical Industry-Supply Chain Security-Purdue Pharma-Cargo Theft
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..
Tuesday, 3 April 2012
Pharmaceutical Companies-Pharmaceutical Industry-Government Programs-340B Program
While the recently released Proposed Rule has the pharmaceutical industry scrambling to begin to strategize how it might need to adapt and change post- Final Rule, the AMP guidance is not the only thing the pharmaceutical industry is talking about.
At the Government Programs Summit, industry professionals will be on hand to discuss not only the AMP Rule, but the 340B pricing program, Medicare Part D, Medicaid Managed Care, Medicare Part B, ASP Pricing and State reimbursement. You will walk away with a thorough knowledge of how various pharmaceutical companies are addressing current challenges and questions with each program to take back and implement at your office.
Session Highlights:
? Improve the Integrity of the 340B Program
? Impact on Manufacturer of Multiple Mechanisms for Reimbursement from States
? Strategies to Overcome the Implementation and Process Challenges of Part D
For more information and these sessions, download the brochure here.
The Government Programs Summit this March 14-16, 2012 in Baltimore, MD! If you have any questions about the program, please feel free to contact Jennifer Pereira at jpereira@iirusa.com. read more..