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

FDA ENFORCEMENT BILL IS UNLIKELY TO BE RESOLVED BEFORE OCTOBER, House Energy & Commerce/Health Subcommittee Counsel William Schultz suggested at a Feb. 10 Food & Drug Law Institute meeting in Washington, D.C. Referring to the position that will ultimately be taken on the legislation (HR 3642) by regulated industries, Schultz said: "Whatever happens, we'll know by the end of next October." Schultz described two possible industry strategies "if the bill is passed next October." Industries regulated by FDA can persist in staunch opposition to the bill or begin to negotiate provisions more to their liking, he said. "It really remains to be seen where the regulated industries [will] come out on this bill." Although associations representing companies regulated by FDA heretofore have opposed HR 3642, Schultz said they could follow the example of the food trade groups during the negotiations on the Nutrition and Food Labeling Act of 1990. "A number of trade associations came in, and there was actually a very fruitful negotiation, and we were able to address many of the problems and still retain what we thought was a very strong bill," he noted. On the other hand, Schultz continued, opponents have been stonewalling the legislation and successfully have appealed to the Bush Administration to oppose it. However, he said, House and Senate sponsors could obtain the votes to move the bill through Congress. The Hill lawyer said prospects are "very good" that HR 3642 will pass the House because the bill "is a very high priority for" Energy & Commerce Committee Chairman Dingell (D-Mich.) and Health Subcommittee Chairman Waxman (D-Calif.), and "it's not often that when Waxman and Dingell agree on something they can't get it through the House." If Congress passes the bill "in the middle of an election" season, Schultz suggested that industry opponents should not count on a presidential veto because "you just don't know what the [Bush reelection campaign team's] calculus is going to be." Schultz hinted that the bill's congressional sponsors will delay a vote on HR 3642 until October, and he suggested that it will be politically risky to veto a consumer protection bill. Therefore, he said, if the legislation is sent to the White House in October, the industry's strategy for defeating it "will be to some extent left up to chance." Schultz noted that President Bush told the National Grocers Association Feb. 4 that he will veto the FDA enforcement bill. However, Schultz pointed out, the President promised to veto "legislation with excessive regulation in it." The Health Subcommittee counsel commented: "Of course, I think everybody would agree that a bill that includes over-regulation...should be vetoed. The issue is whether this one qualifies." Regarding the generic drug debarment legislation (HR 2454), Schultz noted that "we come back this session with a bill that has passed the House and some unclear signals from the Senate." One possibility is "that something very similar to the bill that didn't go through last year will go through early this year," he suggested. "The other possibility is...hearings and perhaps some broadening of the bill, and that could go a lengthier route." Although HR 2454 has passed the House and is pending in the Senate, the House reportedly has suggested additional amendments for the other chamber to consider. The Senate may pass the bill expeditiously if the Pharmaceutical Manufacturers Association agrees to or develops alternative language to a provision involving liability of "high managerial agents," i.e., pharmaceutical company executives. Sen. Durenberger (R-Minn.), who had concerns about the provision late last year, has since accepted it.

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

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