The discussion over the looming Supreme Court decision on the Affordable Care Act has largely centered on whether individuals should be required to buy health insurance and how the government can best go about broadening coverage among Americans--with Republicans and Democrats taking opposing stances. But the controversy and debate has largely ignored the fate of some key pieces of legislation that the biopharma industry fought long and hard to achieve.
Industry lobbyists were able to win bipartisan support not only for a provision in the ACA that extends market exclusivity for biologics to 12 years, the legislation also provided the authority needed by the FDA to hammer out a regulatory pathway for biosimilars. And since the ACA passed, some of the world's most prominent drug developers--like Merck ($MRK) and Amgen ($AMGN) and Biogen Idec ($BIIB)--have been teaming up with some major league partners to invest in the first big wave of biologic copies. During the meeting at BIO 2012 in Boston earlier this week, the FDA's Janet Woodcock noted that a decision to toss out all of the ACA--one of the options the Supreme Court is considering--would strip them of the legislative authority they have to have in order to proceed.
"For years people were saying, 'Why won't FDA do this? Tthe Europeans have, why won't the FDA?," Woodcock said during an FDA Town Hall panel. "Well, we didn't have the statutory authority to do it. And we need the statutory authority. That's what our lawyers say. And I've learned from years working at a regulatory agency to listen to our lawyers even if I don't want to."
The prospect of a complete rejection is raising some distinct fears among executives in the industry.
"The biggest thing that could go wrong for us is if the whole thing gets overturned and we have to deal with the risk of uncertainty," said Rachel K. King, the CEO of GlycoMimetics, according to a story in The Boston Globe.
- here's the story from The Boston Globe