Paying for Safety - Pharmaceutical Executive

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Paying for Safety
FDA legislation to boost user fees even more to support new testing and disclosure requirements


Pharmaceutical Executive


In addition to authorizing REMS, the legislation gives FDA authority to expand safety requirements for all drugs. Sponsors will have to submit more information about ongoing clinical trials to the clinicaltrials.gov/ Web site and publicly disclose study results, as described in Pharm Exec news last month. Other provisions that fall under the drug safety umbrella include:

•Speedy labeling changes. Under current policy, discussions between sponsors and FDA about label revisions may take months, or even years. The legislation sets time frames for negotiating such changes, including the need for black-box warnings and additional information on contraindications, precautions, or adverse reactions. The system provides a process for sponsors to question a requested change and for resolving disputes. But if FDA insists on new labeling language, it will have more teeth to compel compliance.

•Timely completion of postapproval studies. FDA now may request additional clinical trials and analysis following approval of a new drug, but it lacks authority to levy penalties on companies that fail to complete studies as expected. Sponsors claim that many studies that seem reasonable when a new product is approved for market later appear inappropriate, and many projects have trouble enrolling patients in trials after a drug becomes widely available. The new policy calls for discussion of postapproval study options earlier in the approval process to ensure that agreements are realistic and address important issues. FDA also can request more postapproval studies after a drug is on the market. Manufacturers will propose timetables for completing studies, report periodically on their progress, and explain why they cannot meet set goals—and why they should not be penalized for delays.

Curbs on conflicts-of-interest. The legislation reflects Congressional concerns that too many members of FDA advisory committees have financial links to industry. Although policymakers recognize that these panels can benefit from input from well-known experts, despite any conflicts, the legislation aims to make advisory committees more objective on safety issues by limiting use of waivers to permit such testimony. Congress also wants FDA to more actively solicit scientists and medical experts without financial ties to pharmaceutical companies to improve the advisory process.

Expanding Information

A prime initiative for reducing drug safety problems is to modernize FDA's electronic information system. User fees have supported improvements in the agency's IT infrastructure for new drug review and oversight; now PDUFA IV will provide added resources to establish an all-electronic regulatory submission-and-review environment over the next five years. The envisioned system will allow manufacturers to send in applications electronically with automated cross-links to previously submitted data, and FDA reviewers will be able to retrieve all relevant submissions and utilize tools for searching and analyzing data.

A modern IT system also would improve FDA's current adverse event reporting system (AERS) for collecting and analyzing AERs from manufacturers, health professionals, and patients. Congress also supports FDA efforts to build a more robust active surveillance system instead of relying on spontaneous reports to signal problems. Additional resources will permit FDA to contract with government health programs and private health plans to access population-based epidemiological data on millions of patients that can better inform postmarketing drug surveillance. Expanded collaboration with payers, academics, and the Centers for Education and Research on Therapeutics will enable FDA to learn more about how a drug works in real-world postmarket circumstances, including the extent and outcomes of off-label drug uses.

Jill Wechsler is Pharmaceutical Executive's Washington correspondent. She can be reached at


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