According to a post in FiercePharma, the Obama administration is proposing to shorten the length of biologics exclusivity to seven years from 12 years. This push to get drugs to the less expensive generic market is short-sighted and dangerous.
I went back to a post from Fierce just two years ago as they asked “What can we expect from Obama’s FDA?” Here was the answer:
“The principal question facing President Obama’s FDA will not revolve around drug safety or transparency, says Robert Goldberg, Co-founder and vice president of the Center for Medicines in the Public Interest. Obama’s FDA will have to answer the question, ‘Who lost innovation?’”
The answer is simple: THE FDA IS KILLING INNOVATION!
As Steve Forbes correctly writes in his recent article “How the FDA May Be Killing Us”:
“FDA’s behavior is no surprise to the organization’s watchers: Approve a medication that has an unintended side effect and congressional headline-seekers will be giving officials the third degree. Better to let people die by depriving them of new medicines than to be excoriated by the likes of McCarthyite demagogues such as Representative Henry Waxman (D-Calif.).”
Forbes goes on to quote the recent book by David Shlaes Antibiotics: The Perfect Storm:
“Regulatory agencies like the FDA are contributing to the problem with a constant barrage of clinical trial requirements that make it harder, slower and more costly to develop antibiotics.” Another bad guy: “The National Institutes of Health was for many years [biased] against funding antibiotic research.”
Federal bureaucrats need to stop the bloviating and recognize government is not the answer to innovation it is the antithesis of innovation.
Get out of the way! The new Congress has a lot of work to do, but nothing could have a bigger impact on rejuvenating an innovating environment for drug and device makers than a total overhaul of the FDA.
Do you have a nightmare story of lengthy trials or burdensome regulatory hurdles getting a drug or device to market? Send me your story.