FDA Waves a Big Stick - Pharmaceutical Technology

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FDA Waves a Big Stick
Agency officials and manufacturers anticipate stricter enforcement of drug safety and quality.


Pharmaceutical Technology
Volume 33, Issue 6, pp. 30-35

Action on the Hill

Congressional leaders indicate high interest in bolstering FDA leadership and authority. The Senate HELP Committee and then the full Senate moved quickly last month to confirm Hamburg as FDA commissioner, stressing the need for a strong agency to deal with the swine-flu outbreak, as well as food and drug-safety issues.

Kennedy and Sen. Charles Grassley (R-IA) also reintroduced legislation authorizing added FDA user fees to support more inspections of drug and medical product manufacturers. The measure would give the agency authority to issue subpoenas and to detain suspect products. Domestic and foreign manufacturers, including producers of active pharmaceutical ingredients (APIs), would have to register with FDA.

The measure is similar to the drug section of legislation backed by Rep. John Dingell (D-MI), which, at press time, was pending before the House Energy and Commerce Committee. That committee's chairman, Henry Waxman (D-CA), has indicated interest in enacting only the food-safety portion of the bill, but even that would grant FDA subpoena authority for all regulated products.

Building on FDAAA

These legislative proposals would enhance the added enforcement powers under FDAAA, which boosted fines and criminal penalties for violative activity. FDA gained a "huge new arsenal" of enforcement tools under the act, noted attorney Marc Sheineson at the FDLI conference.

To date, FDA has not brought a case under these new authorities, added Autor, "but when we need to use it, we will." She pointed to the agency's speedy action to halt production of drugs by KV Pharmaceuticals (St. Louis, MO), which resulted in a recall of 175 products and blocked shipment of thousands of lots. Autor also emphasized that FDA is taking data integrity seriously, citing recent FDA action to invoke its Application Integrity Policy against Indian manufacturer Ranbaxy's Paonta Sahib facility.

Autor discussed FDA's campaign to remove unapproved drugs from the market as well. With action taken against 12 classes of drugs, numerous consent decrees and injunctions issued, and $24 million in drugs seized from one company, the campaign has affected more than 200 manufacturers and 500 products.

The latest crackdown came in March when FDA cited nine companies for marketing 14 unapproved narcotic therapies. The message to manufacturers, said Autor, is that important drugs must have FDA approval. "We still see industry as somewhat complacent" about this, she says, promising more aggressive action to show that the agency means business.

Stress on safety

In addition to waving a big stick, FDA is taking steps to enhance the safety of prescription drugs during development and following market approval. The agency's Safety First program aims to update agency operations to improve its ability to identify and track drug safety issues, explained Gerald Dal Pan, director of CDER's Office of Surveillance and Epidemiology (OSE), at the FDLI conference. This includes giving OSE an "equal voice" in evaluating and overseeing new drugs and expanding OSE operations. The office's staff increased from about 120 to 170 during the past year and may top 200 by the end of 2009.

A related but more externally oriented Safe Use initiative seeks to prevent misuse, abuse, and inappropriate use of drugs by patients and health professionals. OSE is implementing several key FDAAA programs, including the review of Risk Evaluation and Mitigation Strategies (REMS) in drug applications and efficacy supplements, which require additional postmarket studies and the negotiation of safety labeling changes.

FDA is upgrading its adverse event reporting system to gain more reports from health professionals and to improve its internal capacity for assessing such information. The upgrade involves establishing an FDA Adverse Event Reporting System to hold and analyze adverse-event data. The system will first test safety reports involving food, veterinary drugs, and pet food and then expand to include medical products.

OSE also is implementing a new drug proprietary-name review program with the aim of shifting this task to manufacturers during the next few years. A pilot program scheduled to launch this fall will weigh whether FDA can review name proposals within set timeframes. FDA has issued draft guidance on how to submit a name evaluation and is developing further guidance on best practices for naming, labeling, and packaging of drugs and biologics to reduce medication errors.


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