Regulatory Beat: Crawford Faces Policy and Program Challenges - FDA's top priority is to restore public confidence in review and regulatory programs for biomedical products. - BioPharm International


Regulatory Beat: Crawford Faces Policy and Program Challenges
FDA's top priority is to restore public confidence in review and regulatory programs for biomedical products.

BioPharm International

Moves to expand FDA authority or restructure agency operations will gain a broader hearing in coming months as Congress prepares to tackle reauthorization of the Prescription Drug User Fee Act, which expires in 2007. FDA, biotech companies, and special interest groups are gearing up for the debate, which will require Crawford and his staff to articulate agency positions on a host of hot issues:

  • Generic biologics. With patents expiring for some $10 billion worth of branded biotech therapies over the next three years, FDA is under pressure to describe a legal and regulatory pathway to permit consumer access to lower-cost, follow-on biopharmaceuticals. Crawford now believes that improved understanding of complex molecules may make it possible to characterize follow-on products. The agency has been examining scientific and technical issues related to developing and testing generic versions of approved proteins, and Crawford stated the agency would issue a report describing such approaches this fall. The challenge for FDA is to retain incentives for developing new biotech therapies while allowing public access to lower-cost, follow-on treatments that meet quality and equivalence standards. In the end, Congress may step in to provide FDA with clear legal authority to approve generic versions of biologics.
  • Vaccine and drug shortages. Policy makers and health authorities are watching flu vaccine supplies carefully for the coming flu season. At the July appropriations hearing, questions about flu vaccine manufacturing prompted Jesse Goodman, director of the Center for Biologics Evaluation and Research (CBER), to report that FDA had completed inspections at Chiron's Liverpool plant and that "substantial progress has been made." But Chiron continues to experience vaccine manufacturing problems, and growing concerns about inadequate US preparedness for a possible avian flu pandemic will require FDA's continued attention to this issue.
  • Drug importing. FDA has blocked individuals and third parties from bringing in drugs and biologics from other countries, claiming it lacks the authority and resources to ensure the safety and quality of such products. This stance has infuriated members of Congress who consider broader importing a good way for American consumers to access lower-cost prescription drugs. Legislators will continue to press for drug importing measures.
  • Drug marketing. Crawford has expressed concerns about the increasing volume of direct-to-consumer advertising, a position echoed by members of Congress and health professionals. Pharma manufacturers have developed guidelines recommending curbs on promotion of newly approved drugs and on intimate ads in prime viewing time. Critics contend that voluntary curbs won't solve these problems, and Congress is likely to step in if the industry guidelines fail to address public complaints.


Next year (2006) will mark FDA's 100th anniversary, and Crawford already is eyeing opportunities to celebrate the agency's achievements in ensuring public access to safe foods and innovative medical products. This celebration will coincide with FDA's relocation to White Oak, a move Crawford regards as heralding a new chapter in FDA's history. For the first time in decades, the agency's multiple operations will be housed in close proximity to each other, making it easier to interact and collaborate. For patients and policy makers to share this enthusiasm, the new commissioner will have to convince them that FDA is up to the task of keeping truly dangerous medical products out of patients' hands while supporting continued biomedical innovation.

Jill Wechsler is BioPharm International's Washington editor, 7715 Rocton Avenue, Chevy Chase, MD 20815, 301.656.4634,

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