Drugs

FDA ‘Addicted’ to Industry Money: POGO Reports

David McFarland

— 3 min read
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Two lengthy, detailed reports from the Project on Government Oversight (POGO) “document the extent to which FDA depends upon funding from the pharmaceutical industry — money that comes with extraordinary strings attached.” The group calls on Congress to reject the latest reauthorization of the Prescription Drug User Fee Act (PDUFA) and instead fully fund the agency from appropriations.

Almost $800 million of the agency’s 2015 budget came from user fees paid by regulated drug companies, POGO says. The watchdog group says that while many agencies impose user fees, FDA’s use of them stands out because reauthorizing the fees requires the agency to negotiate with companies on the terms of the agreement. And while FDA is also supposed to hear from patient groups as a counter to the industry influence, POGO found that many of the patient groups that are involved have significant funding themselves from industry and include industry representatives on their boards.

“This makes a mockery of the drug approval process,” says POGO executive director Danielle Brian. “The input by patient and advocacy groups should be a bulwark against excessive industry influence, but if they rely heavily on funding from drug companies and put industry executives on their boards, it’s a sham. There’s nobody truly advocating on behalf of public safety.”

The first POGO report, “FDA Depends on Industry Funding: Money Comes with ‘Strings Attached,’” traces the history of the drug user fee program and takes an in-depth look at the 70 “closed door meetings” at which negotiations for PDUFA 6 were held. It cites opinions of critics who say that the industry funding has adversely affected the agency’s drug approval processes.

In also presenting the positive case for user fees, it quotes former FDA commissioner David Kessler that “on balance, FDA is stronger” because of the fees. But, he cautioned, “We have to be mindful that subtle biases and effects could creep into the system.”

POGO says the PDUFA 6 commitment includes “an extensive review and rethinking of how FDA does its job. Tentatively, it has set FDA on a course to increasingly look beyond data from controlled clinical trials — the costly mainstay of medical research — when assessing drugs. In the commitment letter, in buzzwords that track industry’s wish list, FDA has pledged to pursue the use of ‘patient-reported outcomes’ and ‘real-world evidence.’ The agency also promised to explore ‘novel clinical trial designs,’ including ‘highly innovative’ ones for which ‘simulations are necessary.’” The report says that some observers fear that such approaches may not be scientifically sound, that they could be more susceptible to manipulation, and that they could lead to lower standards.

The report also quotes an agency slide show that said that “user fees pay for services that directly benefit fee payers.” And it quotes PDUFA 6 FDA chief agency negotiator Theresa Mullin as saying that because it’s a fee, it is intended to benefit directly “the fee payers and benefit them in a way that exceeds the benefit to the general public.” The slide show also said that the fees are intended to “speed and enhance the review process.”

POGO points out that since user fees were first enacted in 1992, the drug review process has indeed gotten much faster. FDA has said that the median time from manufacturer application to approval for drugs or biologics with a new molecular entity has dropped from 19.1 months in 1993 to 8.5 months in 2015. “This means that, typically, new drugs could start generating revenue in less than half the time,” POGO says.

The second report, “In FDA Meetings, ‘Voice’ of the People Often Funded by Drug Companies,” looks at the many patient advocacy groups listened to by FDA that have strong financial ties to the drug companies. It pays particular attention to the National Health Council, which describes itself as “an umbrella organization of patient advocacy organizations, which provide a united voice for people with chronic disease and disabilities.” The group’s CEO has spoken out in favor of the PDUFA 6 agreement, POGO says, noting the council board members include the heads of Pharmaceutical Research and Manufacturers of America and the Biotechnology Innovation Organization, as well as executives from several drug companies. The group also lists many drug companies and other industry groups as its “sponsors.”

POGO closes the second report with these recommendations: 

  •          end reliance on user fees and use federal appropriations to fund all of FDA’s work on prescription drugs;
  •          if user fees are retained, eliminate the requirement that FDA negotiate the fees with regulated industry;
  •          increase transparency of negotiation and consultation meetings if neither of the first two recommendations can be adopted; and
  • ·       require conflict of interest disclosures for stakeholders such as patient groups.

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