PDUFA and the Critique of Pure Reason

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  • 03/23/2012

Immaturity is the incapacity to use one's intelligence without the guidance of another. -- Immanuel Kant

Is "Kant" in the FDA vocabulary?

Here’s the latest House PDUFA
discussion draft being circulated by the House Energy and Commerce Committee.

As pointed out in the Pink Sheet, guidance development would take on a much larger and likely more extensive role at FDA if provisions in the draft are ultimately approved. The draft, would require FDA to give at least three months’ notice before it intends to issue a certain type of draft guidance and solicit public comment.

New, more rigid guidelines for public participation prior to issuing some draft guidance documents, as well as a requirement that they be finalized within a year, likely would require an increase in agency resources devoted to those efforts.

The more predictable schedule also would favor industry by ensuring the waiting period for FDA thinking on a subject would not be potentially unending. Industry typically complains about the uncertainty of FDA policy on many subjects.

The rule would apply to a guidance that “sets forth initial interpretations of a statute or regulation, sets forth changes in interpretation or policy that are of more than a minor nature, includes complex scientific issues, or covers highly controversial issues,” according to the draft.

A clause in the proposal allows the agency to skip the advance notice if it is impracticable, unnecessary or contrary to public interest, but it would still be required to meet with stakeholders during a three-month period beginning the day the guidance is issued.

Once a draft guidance is released, FDA would be required to finalize it no more than 12 months later or it would be considered null and void, according to the discussion draft.

Comprehensive reviews of final guidances also would be required every five years under the bill to ensure they are not “outmoded, ineffective, insufficient or exceedingly burdensome.”

The provision would subject FDA to a much more formal schedule of guidance development. While the intention appears to exclude routine guidance updates from the rule, it would be easy to place most, if not all, new agency guidance, into one of those categories, especially “highly controversial” and “more than a minor nature.”

The schedule would create more pressure on the agency to finalize guidances before the one-year deadline, which could leave them incomplete or rapidly outdated. A more structured guidance development process ideally would prevent situations where industry has been penalized for violations of FDA policy, yet still waited for years to receive formal agency thinking on the subject.

Sponsors have complained the agency changed its guidance on clinical trial endpoints in the midst of a development program, making continuation more complicated.

FDA is clearly being forced to battle against congressional efforts to adjust its mission to focus more on issues of innovation … and PDUFA’s first principle of predictability.

A provision would add to FDA’s mission that it would strive to establish a regulatory system that “protects the public health and enables patients to access novel products while promoting economic growth, innovation, competitiveness, and job creation among the industries regulated by this Act,” according to the draft.

The package includes reauthorizations of the prescription drug and medical device user fees, as well as new programs for generic drugs and biosimilars.

The four user fee cycles would run from FY 2013 through FY 2017.

The user fee package is expected to be ready for passage soon. Health Subcommittee Chairman Joe Pitts, R-Pa., already has stated he wants the bill signed by President Obama by June.

He alone is free who lives with free consent under the entire guidance of reason. -- Baruch Spinoza

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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