Ensuring safety
Hamburg expressed concern that the strong "anti-government and anti-regulation sentiment" expressed in some legislative proposals
could "lower FDA's high public health standards that have served patients, consumers, industry, and the public health for
so long, and so well." High standards for safety and efficacy, she said, "will ensure that innovations actually help patients,"
and that they receive coverage from third-party payers.
FDA moved to highlight its increased commitment to drug safety over the last five years in a report from the Center for Drug
Evaluation and Research (CDER) on "Advances in FDA's Safety Program for Marketed Drugs." CDER now spends equal resources on
postmarket oversight as on premarket approval, reported Director Janet Woodcock, and new authorities provided by the FDA Amendments
Act of 2007 have enabled the agency to require more than 385 postmarket drug safety studies, to mandate 65 new safety labeling
changes, and to initiate 64 risk evaluation and mitigation strategies (REMS) since 2008.
However, a report from the Institute of Medicine on "Ethical and Scientific Issues in Studying the Safety of Approved Drugs"
calls for FDA to do more to monitor and disclose safety issues involving marketed medicines. The expert panel, which launched
this study in 2010 to help FDA prevent future Vioxx-type safety crises, advised the agency to create a comprehensive, publicly
available document that would map drug risks and safety concerns throughout the product lifecycle. CDER officials dismissed
that idea, noting that developing such a Benefit and Risk Assessment and Management Plan, or BRAMP, for every approved drug
would be "challenging" given the agency's limited resources and probably would require lengthy new rulemaking.
Going global
What FDA would like to see in the PDUFA legislation is enhanced authority to ensure the safety and quality of drugs and active
ingredients now imported from all over the world, as described in its new report on "Global Engagement" and last year's "Pathway
to Global Product Safety and Quality." These documents note FDA's increased overseas presence through its network of international
offices, as well as efforts to strengthen regulatory agencies in other countries, to collaborate on science-based standards,
to share knowledge and inspection resources, and to develop a range of joint surveillance and preparedness activities.
At the FDLI meeting, Hamburg cited several legislative provisions that would enable the agency to deal with rising global
drug production: make it easier for FDA to share confidential information with trusted regulatory authorities; enable FDA
to refuse admission and to destroy unsafe drug imports; require manufacturers to report to FDA threats to the supply chain;
and require a "robust" system to track and trace drugs throughout the supply chain.
The proposed generic-drug user-fee program, she noted, will help by supporting more frequent inspections of foreign manufacturers
of active ingredient and drug products. There seems to be agreement that manufacturers should report earlier to FDA about
looming shortage situations. But industry appears wary of legislation that sets stiff penalties for a host of reporting and
disclosure requirements. Manufacturers don't want to invest millions in a system able to track drugs down to individual vials.
The debate continues.
Jill Wechsler is Pharmaceutical Technology's Washington editor, 7715 Rocton Ave., Chevy Chase, MD 20815, tel. 301.656.4634, jwechsler@advanstar.com
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