The FDA has spent decades talking about how its job is to make sure all kinds of U.S. medical products are safe to use, and effective. Now it’s coming out with a new strategic outline on how it intends to do all that same stuff, while also spurring the development of more innovative drugs and devices that will help the U.S. hold onto its competitive advantage in the life sciences.
The FDA commissioner, Margaret Hamburg, today is releasing the 40-page overview with a decidedly non-adversarial title of “Driving Biomedical Innovation: Initiatives for Improving Products for Patients.”
While the full report has some defensive notes in it about how the FDA has already been trying to stir innovation for years through its 2004 Critical Path Initiative and other vehicles, it acknowledged a number of complaints that entrepreneurs, big companies, and investors have leveled against the agency for years. It cites the common beefs about how the agency can be unpredictable; not so good at helping small businesses navigate its processes; not exactly on the technological cutting edge; and inefficient. The FDA now says, after hearing input from various outside groups for months, that it wants to reform by improving its outreach to small businesses; creating a fast approval pathway for certain targeted therapies; improved data sharing; scientific training; and streamlining of processes and regulations.
It cites the familiar refrain to all industry observers about how the government and industry is pouring $95 billion a year into biomedical R&D, and getting fewer returns in the form of novel new products to help patients.
There’s a political backdrop to all of this, of course, as the President and the Congress are deeply worried about the stubbornly high jobless rate. Pharmaceuticals, biotech, and medical devices are three industries in which the U.S. is the undisputed world leader—yet there’s almost universal scorn for an FDA that has become so cautious and bureaucratic that it is stifling those industries and sending much of the U.S. competitive advantage overseas. Some prominent venture capitalists, and industry trade groups, have been pressuring people in the White House and in Congress for months to shake up the FDA, which I wrote about here back in April.
The FDA talks like it has been listening. Hamburg wrote in the report that the agency “is working to position itself not only as a positive driving force in the ecosystem as a regulator, but also to facilitate medical product innovation.”
And Kathleen Sebelius, the U.S. Secretary of Health and Services of which the FDA is a part, added in a statement that: “The Obama Administration is committed to encouraging the entrepreneurs and businesses that are modernizing and strengthening our health care system. The innovation blueprint is another part of our effort to help businesses grow and keep Americans healthy.”
The blueprint is fairly vague in parts, and Hamburg notes in her introduction that it is an ongoing initiative and that it will be expanded.
One venture capitalist, Bob Nelsen of Arch Venture Partners, said he’ll need more assurance the FDA reforms are meaningful.
“It is a positive step that the FDA in recognizing that innovation matters. The verdict is out as to whether they will really change, so I will look for data. The FDA is under bipartisan pressure to re-think their policies that are leading the US to lose its huge advantage in medical devices to Europe, and [prompt] biotech investors like me to start investing in China,” Nelsen said in an e-mail.
“We no longer can justify investing in huge public health priorities like diabetes and Alzheimers, that cry for innovation investment, as a direct result of FDA policies that are muddled, unclear and don’t take patients into account. There is a dialog, and that is certainly a good thing, but as recently as two weeks ago Margaret Hamburg blamed the slow pace of drug approval on the lack of good science, not the FDA, which was a fall out of your chair moment, so we have a long way to go,” Nelsen said.
Still, the FDA document states repeatedly that the agency wants to be more supportive, and cites some of President Obama’s more business-friendly initiatives, such as the “Startup America” program which seeks to encourage high tech entrepreneurship as well as the “Strategy for American Innovation.”
Here’s the quick rundown on some of the programs the FDA has sketched out in its report, which it says should help spur more biomedical innovation:
—The FDA plans to establish a
