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



Executive Summary

HOUSE FDA ENFORCEMENT BILL CONTAINS REDUCED SUBPOENA POWER provisions in a discussion draft circulated on Capitol Hill March 27 by the staffs of Reps. Dingell (D-Mich.) and Waxman (D-Calif.). Freestanding subpoena authority, which was included in HR 3642, has been deleted from the new draft, which would provide subpoena power only in connection with a civil penalty investigation. Section 4 of the discussion draft states that civil penalties may be assessed against anyone who submits false information to or withholds material information from FDA, bribes government employees or destroys or alters material documents. The provision adds that penalties are assessed after hearings and that "in the course of any investigation or hearing," FDA may "issue subpoenas requiring the attendance and testimony of witnesses and the production of evidence that relates to the matter under investigation." A staff analysis of the draft states that "current law allows the FDA to subpoena documents and witnesses in the narrow situation where it has initiated a civil penalty investigation" (21 U.S.C. 333(f)). The analysis further notes that the draft's subpoena provision "is identical to" language in the House-passed debarment bill (HR 2454) and "substantively the same as" a provision in the medical device amendments enacted in 1990. The draft also includes reduced civil money penalties and narrower record inspection authority compared to earlier drafts. On the other hand, additional due process provisions have been included. Perhaps to emphasize the modifications to the legislation, the draft even carries a name change: the "enforcement amendments" are now called the "safety amendments." A cover memorandum to Democratic legislative aides states that the changes were made in "a conscious effort to address the concerns of the Democratic members." Many Democrats voted to support HR 3642 at an Oct. 7 markup by Waxman's Health Subcommittee only after expressing reservations about several provisions in the measure ("The Pink Sheet" Oct. 14, 1991, p. 3). Subcommittee Democrats indicated that they wanted to allow the measure to move forward and to negotiate further changes in the measure before Dingell schedules a markup by the full Energy & Commerce Committee. Republicans, who voiced concerns about the bill during the subcommittee markup before voting against it, are not likely to support the bill at a full committee markup regardless of changes made. President Bush on at least two recent occasions has said he considers the legislation over-regulation and will veto it. Objections voiced at the markup about the subcommittee-passed bill included contentions that its various provisions required due process protections, its subpoena power and inspection authority were too broad and its civil money penalties were excessive. The money penalties provided in the new draft are $15,000 per violation for individuals and $50,000 for companies with maximum fines "adjudicated in a single proceeding" of $250,000 for individuals and $1 mil. for companies. However, if the penalties are assessed for bribery, the maximum fine per violation is $250,000 for individuals and $1 mil for companies. The higher per- violation maximums for bribery coincide with the penalties provided in the debarment bill. HR 3642 provided maximum fines of $250,000 per violation for individuals, $1 mil. for corporations and caps of $5 mil. Inspection authority under the draft permits FDA to inspect facilities and nonfinancial records of prescription and OTC drug makers and medical device firms. FDA may inspect food and cosmetic firms' facilities, as under current law, but the draft also authorizes FDA to inspect the following records kept by food and cosmetic companies: records of ingredients, quality control tests required by regulation, consumer complaints relating to safety, and records pertaining to the time and temperature at which a food is processed. The draft also limits FDA's right to make photographic records of inspections to situations involving "apparent violations" observed during inspections.

You may also be interested in...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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