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

FORMER FDA GENERICS DIRECTOR SEIFE EXPECTED TO RECEIVE COMMUTED SENTENCE due to serious medical problems incurred while in prison. Marvin Seife, MD, who began serving a 10-month sentence at a correctional facility in Texas, was last reported to be in serious condition at the Nix Medical Center in San Antonio. The Maryland U.S. Attorney's office has recommended that Seife's sentence be commuted, a recommendation which is widely expected to implemented by Baltimore federal court Judge John Hargrove the week ending March 20. Seife apparently developed a rapidly progressing infection in his leg while in prison that led to gangrene and ultimately amputation of the limb. The former FDAer was rushed to the hospital on March 6. Seife began serving his 10-month sentence at the Three Rivers Federal Correctional Institution on Feb. 7. The former head of FDA's generic drugs division was found guilty of two counts of perjury by a Baltimore federal court jury in October 1990 ("The Pink Sheet" Nov. 5, 1990, p. 3). The longtime FDAer had been accused of making false statements to federal investigators about meals with industry. He lost an appeal of the verdict in November 1991. The Seife affair has shocked FDA officials and industry members alike, and could well attract national media interest. The lay press followed intently the unraveling of the generic scandal, which led to the prosecution of Seife by then-Maryland U.S. Attorney Breckinridge Willcox. Seife's treatment in prison also raises questions about the quality of healthcare in U.S. correctional facilities. House Oversight/Investigations Subcommittee Chairman Dingell (D-Mich.), who spearheaded many investigations in the generics scandal, has sent a letter to U.S. Attorney General William Barr asking him to look into circumstances surrounding Seife's illness. In 1990, Rep. Dingell and subcommittee ranking Republican Bliley (Va.) praised Seife for his cooperation in the ongoing generics investigation. Full details of the case are not yet known. The Federal Bureau of Prisons apparently initially directed Seife to report to a minimum security prison called Big Spring, where officials referred him to the Three Rivers correctional facility, a medium security prison. When he arrived, Seife was placed in solitary confinement. Seife's shoes were taken from him for some as yet unknown reason, and he was given another pair of shoes that reportedly were too small. He developed a blister that led to an infection in the leg and gangrene. After the leg was amputated, Seife went into septic shock and then a coma. He reportedly has emerged from the coma. Seife, who is almost 68 years old, retired from FDA in December 1989 after 23 years of service, first in the Bureau of Drugs and then as head of the generics division. He came under investigation by the HHS Inspector General's Office after Rep. Dingell was informed by former Warner-Lambert VP-Regulatory Affairs Milton Kaplan in a letter that Seife had had lunch with himself and former My-K President K. C. Bae. Seife denied the lunch and other meals with industry in a sworn statement to FDA investigators, which led to the former FDAer being charged with two counts of perjury in June 1990. At the trial in October 1990, 10 industry members testified to having had meals with Seife ("The Pink Sheet" Oct. 29, 1990, p. 22). Some of the most damaging testimony came from Bae and former FDAer and Quad Regulatory Affairs Director Jan Sturm, both of whom had pled guilty to either giving or receiving illegal gratuities.

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