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Sens. Richard Burr and Tom Coburn Introduce a New Plan to Reform the FDA

April 18, 2012

By Avik Roy

Sens. Richard Burr (R., N.C.) and Tom Coburn (R., Okla.) were last seen in this space proposing the best-yet plan for reforming Medicare. Yesterday, they rolled out a new bill, this one designed to significantly improve the regulation of drugs and medical devices at the FDA. While their plan can’t change the FDA’s fundamental incentive to stall innovation, it does much to make sure the FDA is held more accountable for its actions.

The bill, called the "PATIENTS’ FDA Act," is divided into six titles: (1) improving transparency and accountability in FDA decision-making; (2) recalibrating risk-benefit considerations; (3) reducing unnecessary delays and regulatory burdens; (4) improving the way the FDA gains outside expertise; (5) medical-device regulatory improvements; and (6) improving the FDA’s internal management.

The plan is timely, because it coincides with the every-five-year reauthorization of the Prescription Drug and User Fee Act (PDUFA), which has come to be the main instrument for Congressional reform of FDA policies. Many stakeholders, most notably the big pharmaceutical companies, basically like PDUFA the way it is, and are lobbying for a "clean PDUFA" with minimal modifications to the 2007 version. From their standpoint, they have much more to lose of PDUFA fails to get reauthorized, than they do if the law is revised to improve the FDA’s stance toward innovation.

How the plan would affect pharmaceutical and biotech companies

If the Burr-Coburn proposal were to get incorporated into the 2012 PDUFA reauthorization, it could do a reasonable amount to improve the FDA’s transparency and efficiency. In many ways, the bill requires the FDA to do things that it is already supposed to do—once more, with feeling. Here are some of its notable provisions:

Retract the dumb 2007 conflict-of-interest rules for FDA advisory committees. The bill would repeal the "overly stringent conflicts of interest requirements" that were put in place in the 2007 PDUFA, provisions that prevent clinical thought leaders from participating in FDA advisory committees. The rules bar anyone who has taken any form of compensation from drug companies from participating in these panels. The problem is that nearly all physician experts are involved in conducting clinical trials, which involve receiving compensation from drug companies for the costs of conducting the trials.

More accountability for meeting drug-review deadlines. The FDA has been increasingly failing to meet its PDUFA-mandated deadlines for giving companies approval decisions on new drug applications. The PATIENTS’ FDA Act would require the FDA to "report [to Congress] on a deeper level detail with respect to the performance goals agreed to in the prescription drug, generic drug, and biosimilar user fee agreements," and hold individual reviewers accountable for their speed in reviewing applications.

Stop forcing companies to do unnecessary and expensive busywork. The bill’s summary notes that "some FDA reviewers request reams of additional information about a drug or device that is beyond the scope of data needed to meet the FDA’s approval standard." The FDA will be required, under the bill, to "document the scientific and regulatory rationale" for such decisions, and review within one year "the costs and adoption of the least burdensome approaches to regulation." The bill would also codify the FDA’s "commitment to improve on patient risk-benefit considerations…to ensure accountability for fulfilling…the user fee agreements."

Take more advantage of clinical trials in other countries. The bill would require FDA to work with "other specific regulatory authorities of similar standing" to encourage uniform standards for clinical trials. (The Geneva-based International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, or ICH, performs many of these functions.) FDA will also be instructed to help sponsors "minimize the need for duplication of clinical studies, preclinical studies or non-clinical studies."

Modifications to the Medical Device user fee agreement

The bill also seeks to improve the Medical Device user fee agreement, which was born in 2007. The bill seeks to require that "the reviewer assigned to handle [device] submissions to have prior experience with that type of device or technology," and prohibits the FDA from "disapproving medical research based on a determination that the device will not meet the standards for approval or clearance." It would strive to improve and increase the FDA’s use of third-party reviewers of device applications and inspections.

The bill will require FDA to "publish detailed review summaries for 510(k) clearance" so that everyone can learn from the FDA’s thought process: something that would also be quite useful in the drug-development process. It would require the FDA to ensure that a manufacturer would not have to submit an entirely new 510(k) application if a modification to an already-approved device is "validated by the same method…applied to the original device."

Overall management improvements

The bill would require the FDA to "develop a strategy and implementation plan" to advance regulatory science, and to "track and annually report on their progress against their identified priorities." The FDA would be required to "contract with an independent management company to conduct an assessment of all of the drug review and approval processes" and issue an "integrated strategy and management plan."

The bill highlights a 2009 GAO report that found that the FDA has made "mixed progress in establishing IT management capabilities that are essential in helping ensure a successful IT modernization effort."

The bottom line: A solid effort at addressing an intractable problem

A lot of the Burr-Coburn plan involves requiring the FDA to do things it’s already supposed to be doing. But there are areas where Congressional action would be especially useful: in improving the accountability and transparency of FDA decisions; in modernizing the FDA’s use of information technology, given the enormous amount of clinical data it must track; reforming the agency’s clumsy conflict-of-interest rules; and making sure the agency is always thinking about the costs, as well as the benefits, of retarding innovation.

In these areas, the bill is a good start. It will be interesting to see what kind of reception it gets in Washington and New Jersey.

The basic problem with the FDA is its perverse incentives. The agency gets punished by Congress and the public when an approved product runs into safety problems, whereas nobody complains about the patients who are harmed when an important new medicine is stalled by the agency. As former FDA Commissioner Andrew von Eschenbach recently put it in the Wall Street Journal, "Until FDA reviewers can be scientifically confident of the benefits and risks of a new technology, their duty is to stop it—and stop it they will."

It will take far-reaching reforms to meaningfully change this dynamic. But every little bit helps.

Original Source:



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