The FDA Wants You!
US regulators have published updated draft guidance on recommendations for distribution of scientific and marketing materials related to unapproved uses of medical devices, drugs and other products under Food and Drug Administration oversight. The agency is accepting public comments on the guidance through April 2014.
Device manufacturers intending to distribute information on unapproved uses of their products should take steps such as peer review, separation of scientific information from promotional or marketing materials, disclosure of any financial ties authors or publishers of materials may have to featured devices or manufacturers, and systematic reviews of existing clinical or scientific evidence.
It is commendable of the FDA to accept outside help from the public; however, I’d like to see the FDA go one step further and create an ongoing task force of knowledgeable industry insiders and physicians to assist in the approval process of the 510K and PMA. The prevalence of off label marketing can best be summed up from the recent shocking and disturbing headlines , regarding billion dollar fines from off-label promotion from the USDOJ’s press release.
While this is exciting news that companies are being held accountable financially the press release should also include in the title the name of the drug and who was CEO during the time the crimes were committed).
Pharmacia & Upjohn Company a subsidiary of Pfizer was fined $2.3 billion for the off-label promotion of Bextra while Jeff Kindler was CEO of Pfizer.
Janssen Pharmaceuticals a subsidiary of Johnson & Johnson was fined $2.2 billion for off-label promotion and kickbacks regarding Risperdal while Alex Gorsky was CEO of Johnson & Johnson.
As consumers, patients, taxpayers and potential employees, shouldn’t we be able to follow these CEO’s and their statistics much like our favorite baseball players? It just might be time to start sending some down to the minors.
Read the full story here.