Regulatory Focus™ > News Articles > Have an Idea for Better Regulating Pharmaceuticals? FDA Wants to Know

Have an Idea for Better Regulating Pharmaceuticals? FDA Wants to Know

Posted 15 March 2013 | By Alexander Gaffney, RAC

Have a great idea for a policy or guidance document that would stand to benefit the pharmaceutical or biologics industry? The US Food and Drug Administration's Medical Policy Council, an offshoot of the Center for Drug Evaluation and Research (CDER), wants to hear your ideas.


The council, which was created in January 2012 by CDER to coordinate the center's development of medical policy, communications and guidance documents, is currently chaired by Rachel Sherman, associate director for Medical Policy at CDER. Other participants include CDER Director Janet Woodcock, Deputy Center Director for Clinical Science Robert 'Bob' Temple, Director of the Office of New Drugs John Jenkins and Director of the Office of Surveillance and Epidemiology Gerald Dal Pan.

According to FDA, the council is primarily intended to provide a "senior-level forum through which medical policy issues can be raised, considered, developed and implemented."

So if, for example, Janet Woodcock believes that her Center should be developing a manufacturing "scorecard" approach to assessing product quality or Bob Temple wants to create a pathway for better clinical trials, the council can convene to discuss issues and generate the process by which changes can start to happen.

Open for Comments

Critically, that process is also one that is open to public and industry input. In its 15 March 2013 Federal Register notice, CDER calls on both to "Recommend specific topics for consideration by the council."

So, what topics are likely to come up? FDA says nine are likely:

  1. clinical evidence of effectiveness or safety
  2. clinical study/trial design
  3. professional and patient labeling
  4. prescription drug promotion
  5. human subjects protection
  6. bioresearch monitoring
  7. good clinical practice
  8. counter-terrorism drug development/Animal Rule
  9. postmarketing surveillance

Other topics are not excluded, but the specific listing of topic areas seems to indicate the agency would prefer to focus on the development of related subjects.

Criteria for Inclusion

To be considered, CDER said a topic idea needs to meet "one or more of the following criteria:"

  • a novel medical policy issue requiring senior management input
  • an issue on which CDER seems to have taken inconsistent positions
  • an existing medical policy position that should be reconsidered in light of scientific or regulatory advances
  • a complex safety management issue requiring senior management input;
  • a medical policy that may be triggered by a specific product, but that will be applicable to other products
  • strategies for implementation of a new policy

Any entity wishing to propose a policy should comment on FDA's docket, making sure to outline the policy it wishes to recommend, reasons why it should be adopted, methods for implementation and a review of existing policy.

CDER said it will consider all comments submitted, and believes that the process will provide a measure of transparency into the center's policy planning process.

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