Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



This article was originally published in The Tan Sheet

Executive Summary

FDA ENFORCEMENT BILL EXPECTED TO BE REINTRODUCED THIS YEAR in essentially the same form as last year's bill (HR 3642), House Energy and Commerce health subcommittee Counsel William Schultz indicated at a March 24 Food and Drug Law Institute meeting in Washington, D.C. "We haven't worked out exactly what form it will take," Schultz said, but "a lot of [the bill] was done last year and we certainly don't intend to just start over" with an entirely new bill. Crafting new legislation to augment FDA's enforcement authority "will be done after conversations with the [Clinton] Administration" in order to "make a determination where they want to go," Schultz explained. Earlier this year, in a report to the incoming administration, Schultz urged support for FDA enforcement legislation. Last year, HR 3642, which was introduced by Rep. Henry Waxman (D-Calif.), cleared the full House Energy and Commerce Committee in July, but died before reaching the House floor. A Senate version of the bill (S 2135), introduced by Sen. Edward Kennedy (D-Mass.), never reached the Senate Labor and Human Resources Committee for consideration. In addition, the legislation faced an uphill battle because of the Bush Administration's promise of a presidential veto and Sen. Orrin Hatch's (R-Utah) concern with the legislation's impact on nutritional manufacturers. FDA Deputy Chief Counsel for Regulations and Hearings Linda Horton speculated at the meeting that the legislation's chances have improved since last year's election given that "the new administration's views [may] more clearly resemble FDA's traditional views" of its enforcement role. A reintroduced bill "will receive serious attention" in the current Congress, she suggested. "It might actually be passed." Horton pointed out that enforcement legislation may be a way for FDA to get "explicit authority" to require reporting and to gain access to records during inspections of OTC drugs. "In my humble opinion," she said, "there is need for some action either through legislation or rulemaking or some combination of the two to take care of this situation and meet FDA's needs to be a competent regulatory body." Horton added that "legislation is the most obvious way to go." Waxman's HR 3642 would have given FDA inspectors access to "all things (including equipment, finished and unfinished materials, containers, labeling, records, file, papers, processes, controls, and facilities) bearing on whether the articles are in violation" of the FD&C Act. The FDA attorney referred to adverse drug reporting for OTCs as "a compelling case" for requiring reporting and inspection authorization. "In FDA's view, these two things -- reporting and inspections -- need to go hand-in-hand," Horton said. FDA needs to be able to ascertain whether a firm is reporting adverse events that need to be reported under the ADR criteria, she explained. Horton called ADR reporting for OTCs a "high priority" for FDA, and predicted that "there should not be a huge amount of new reporting" stemming from the "effort to apply ADR reporting to OTC drugs." If a product is a nonprescription drug, "it should be a safe drug [and] there should not be a whole lot of unexpected reactions from it," Horton stated. "But if there are [adverse reactions from OTC drugs], the agency should know about them so that it can do something effective." FDA has been actively working with industry to establish an ADR system for OTC drugs since an April 1992 hearing of Rep. Ron Wyden's (D-Ore.) House Small Business regulation subcommittee. At the hearing, Wyden expressed interest in introducing legislation to require OTC companies to provide ADR information to the agency. The Nonprescription Drug Manufacturers Association opposed the idea of such legislation. However, the hearing catalyzed a series of discussions and correspondence between FDA and NDMA that basically established that industry was supportive of an FDA regulation for nonprescription drug ADR reporting. Last September, for example, NDMA suggested that the agency develop a system based on FDA's current system for reporting adverse reactions for non-NDA prescription products. FDA's OTC Drug Policy Staff Director Michael Kennedy noted that "there is a regulation [on ADR reporting] in the works because it is obvious that we need it." Kennedy pointed out that NDMA initially had suggested a voluntary program "but it has really come out that what has to be done is some regulation. We are considering that." Horton also told the FDLI audience that, "in the near future," FDA expects to publish a proposed rule establishing "hearing procedures for civil money penalties." "This is part of an effort to put in place internal agency mechanisms for . . . administrative enforcement powers," such as mandatory recalls, debarment and civil money penalties, "because some of the hearing procedures we have now are not particularly well suited for administrative enforcement," she said. Current hearing procedures are "really written with product withdrawals in mind or product denials of approval in mind," Horton explained. However, she noted, the upcoming proposal's hearing procedures "more closely resemble the complaint-and-answer approach that is familiar in civil court litigation." Civil money penalties are currently authorized by the Generic Drug Enforcement Act of 1992, which allows civil penalties for specified forms of misconduct in connection with ANDAs for Rx and OTC generic drugs. Civil penalties also can be applied to biologics recalls, vaccine manufacturer records and reports, and medical devices under other laws. Last year's FDA enforcement bill contained across-the-board civil penalty authority for the agency.

You may also be interested in...

People In Brief

Perrigo promotes in pricing, planning

In Brief

Combe sells most of its OTC brands

Supplement GMP Warning Letters Make Modest Debut In 2010

Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts