A Stronger FDA: PhRMA's and Angell's Prescriptions

Last week, PhRMA's annual meeting in San Antonio brought some unexpected comments on government involvement from the organization's outgoing and incoming chairmen. Merck CEO Richard Clark expanded on the subject he addressed last year: the industry's need to regain the public's trust, while incoming chair AstraZeneca CEO David Brennan, touched on the need for government involvement, specifically mentioning the importance of a stronger, well-funded FDA.

However, the topic PhRMA leaders were discussing was much broader than all that:healthcare reform. Clark noted that real reform will require an unprecedented level of government involvement, opening up the possibilities of price and access controls. However, he said, "The risk is worth it." For more, click here for coverage on My Sanantonio.com

Incoming chair Brennan spoke about industry and government's uneasy partnership. "Our industry can't get there without the government, the government won't get there without us. Quite frankly, we need each other,'Brennan advocated more government R&D funding. “Tripling the funding to the National Institute for Health or the National Cancer Institute would give Americans some early-stage victories,” he said.

He then spoke about the need to move therapies faster from laboratory to patient and the role that a “strong, well-functioning FDA” would play. “Clearly, FDA is doing better than a decade ago, but an understaffed and under-funded FDA is an agency in crisis,” he said. “In 2008, the FDA missed more than 50 PDUFA goal application review dates.”
“We’re working hard for increased appropriations to the FDA so that it is recognized as a watchdog with a full set of teeth. An agency with the technology and people it needs to do a more timely and consistent job in regulating us and bringing innovative treatments to patients.”  He later added that among the top action items, industry should “be advocates for strengthening the FDA so that they can do a more timely and consistent job.”
Brennan also spoke about the EU and how Europe was trying to regain the edge it originally held in pharma innovation---an edge, some say, that was dulled by government regulation. So the “partnership” has its limits.
For the full text of his speech,click here.
That last phrase about industry advocating for a stronger FDA sounds nice. Enlightened. One never hears manufacturers of chemicals calling for a stronger EPA, or companies asking for an expansion of IRS powers.

Unfortunately, to many, it may ring hollow.

In a perfect world, user fees wouldn’t be needed, but it’s not a perfect world.

So far, acting FDA Commissioner Sharfstein hasn’t voiced any ethical objection to the whole concept of industry funding.  Even Rep. Waxman has assumed that user fees would pay for FDA’s enforcement efforts in tobacco.

Today, the objections came loud and clear, from an expected source: Marcia Angell, in an op ed piece that appeared today in the Boston Globe. Among her criticisms are the needs for post marketing safety studies and a three-year ban on DTC ads.

Unfortunately, reading Brennan’s comments on FDA only reinforces one of the points she makes regarding the unfortunately named “user fees:” The public, not the industry, is the “user” of FDA.
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The industry is doing more to improve communications, and other interesting things were discussed during PhRMA’s annual meeting. Among them, an initiative to determine the therapies that appeared to lead to the best patient outcomes, which the WSJ blog discussed today (click here for more), and more efforts to improve public access to medications.

But if PhRMA’s mission, as articulated by its former chair, is to improve the public’s trust, it should also address more of the points Angell makes. Why not have an open debate, televised on its PhRMA TV, and invite past FDA leaders to take part?  This would give Montell more of a challenge, and attract many viewers, and show that the industry's leadership is not afraid to face critics.

AMS