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

More than 10 generic drug manufacturers and "dozens" of industry officials may face criminal prosecution for charges related to submission of false information in ANDAs, House Oversight Subcommittee staff investigator David Nelson predicted at a Nov. 8 meeting of the Human Drugs & Biologics Subcommittee of the Edwards Advisory Committee on FDA. Addressing a first-day session of the FDA subcommittee's Nov. 8-9 meeting in La Jolla, Calif., Nelson said members of the congressional subcommittee "fully expect there will be dozens of individuals and 10 or more generic drug firms and their contractors...prosecuted by the U.S. attorney in Baltimore for the systematic filing of false information and false applications" regarding generic drugs. FDA is "pulling drugs right now from those firms," he added. The congressional aide asserted that "well over 100 generic applications have been shown to be tainted by fraud and false statements to date, and we have no doubt the list will continue to grow." Under the chairmanship of Rep. Dingell (D-Mich.), the Oversight Subcommittee is expanding its congressional investigation of the generic drug industry and plans to probe the following areas, Nelson told the meeting: testing laboratories, industry consultants, new drug evaluation and medical devices. However, Congress is likely to allow FDA and the industry a grace period to adjust to the newly enacted medical device legislation before further oversight hearings are scheduled. "Yet to go on the agenda are inquiries involving the consultants to the industry and possible generic-related improprieties in the new drug sector," he said. The subcommittee is also looking into "the capacity of FDA and the willingness of the secretary of HHS to conduct criminal investigations of any kind involving violations of the [FD&C] Act." Dingell is said to be concerned that the HHS Inspector General has yet to return its investigators to drug diversion law violations and other FDA enforcement efforts. Lawrence Horowitz, MD, who succeeded newly confirmed FDA Commissioner David Kessler, MD, as chairman of the FDA advisory subcommittee, pointed out to Nelson that concern about drug industry contract labs "is not an unfamiliar, new problem for the agency." Currently an investment banker with James D. Wolfensohn Inc., Horowitz was on the staff of Sen. Kennedy (D-Mass.) in the 1970s and was active in Senate investigations into contract labs. Nelson predicted that the 102nd Congress will enact an FDA enforcement bill. "Largely because the [Oversight] Subcommittee has witnessed such extensive agency failure and so much industry corruption, I would expect the 102nd Congress will be ready to pass reforms of the [FD&C] Act," the congressional aide said. A compromise debarment legislation would have been enacted in the recently completed Congress, Nelson added, but it was blocked at the eleventh hour by Sen. Metzenbaum (D-Ohio). "Unfortunately, misguided and venal interests prevented its passage," he said, noting that "a single senator was able to block the compromise bill in the waning days of the session." Subcommittee member Milan Puskar, president of Mylan Pharmaceuticals, whose complaints of uneven reviews of ANDAs by FDA led to the generic industry investigations, asked Nelson who wanted the bill killed. "Do you have any idea who may have helped the senator make up his mind to stop the bill?" Puskar asked. Nelson replied: "There were a lot of lawyers paid a lot of money and a lot of nonlawyers...I'm virtually certain that a key staff aide made the recommendation." Horowitz asked Nelson how FDA could develop a mechanism that "detects and prevents" the kind of corruption uncovered by the generic drug investigations. The congressional aide responded that legal sanctions must be severe enough that the risk of penalties discourage wrongdoing although the agency lacks sufficient resources to monitor the industry adequately. "When you have limited resources, our premise has been that you create penalties sufficiently draconian so that even a small risk of getting caught carries such consequences that firms will be deterred on that basis," Nelson said.

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