When is a draft guidance not a draft guidance?

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  • 10/17/2011

Q: When is a draft guidance not a draft guidance?

A: When it’s 91 days old.

Think it all begins and ends with PDUFA reauth?  Not so fast …

Friday was a busy day for those following FDA reform. 

Some pithy thumbnails from BioCentury …

House Republicans release FDA reform package

Republicans on the House Energy and Commerce Committee Friday released an FDA reform legislative package, including a bill that would prevent the agency from regulating laboratory-developed tests (LDTs).

The Modernizing Laboratory Test Standards for Patients Act, introduced by Rep. Michael Burgess (R-Texas), would prevent FDA from regulating laboratory-developed and direct-to-consumer (DTC) DNA tests under medical device regulations. Instead, marketing would be contingent on labs submitting, and FDA accepting, data that would be posted to a public registry.

Data submitted for LDTs would include clinical validity -- how well a test identifies, measures or predicts a disease, condition or clinical status -- and not clinical utility. Papers published in a major peer-reviewed journal would be sufficient to demonstrate clinical validity. The bill would sharply limit FDA's discretion to reject registry submissions.

Bill seeks relaxed conflict of interest rules

The Cultivating Scientific Expertise to Foster Innovation for Patients Act of 2011, introduced Friday by Rep. Michael Burgess (R-Texas), seeks to help FDA obtain expert advice on advisory committees by eliminating limits on the number of conflict of interest waivers FDA can issue. It would instruct the HHS Secretary, when considering potential conflicts of interest, to consider the totality of the type, nature and magnitude of any financial interest, without focusing on any one factor over another. 

FDA guidance reform bill introduced

The Guidance Accountability and Transparency Act, introduced Friday by Reps. Brett Guthrie (R-Ky.), John Shimkus (R-Ill.) and Mike Rogers (R-Mich.), would require FDA to notify the public three months prior to release of a draft or final guidance document, and to meet with interested stakeholders and solicit public comment prior to publication. FDA would be permitted to bypass notification and consultation if it announces why pre-issuance public notice and involvement is not possible.

Republicans seek to change FDA's mission

Reps. Mike Rogers (R-Mich.), Sue Myrick (R-N.C.) and Marsha Blackburn (R-Tenn.) Friday introduced the FDA Mission Reform Act. The bill seeks to expand the agency's mission to encompass the promotion of medical innovation, job creation and economic development in the industries regulated by FDA. It also seeks to specify that FDA's mission includes using the "best available science," and allowing public participation in its decisions while promoting predictability, allowing flexibility, and reducing uncertainty.

The proposed mission statement would commit FDA to incorporating a "patient-focused benefit-risk framework that accounts for varying degrees of risk tolerance, including for people living with a life-impacting chronic disease or disability."

Who said that FDA issues were dull?


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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