Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

UsernamePublicRestriction

FORMER FDA CHEMIST CHANG GETS ONE-YEAR WORK RELEASE

Executive Summary

FORMER FDA CHEMIST CHANG GETS ONE-YEAR WORK RELEASE, three years of probation and 1,000 hours of community service in an Oct. 3 sentence handed down by Baltimore federal court Judge Hargrove. Charged with two counts of interstate travel in aid of racketeering, Charles Chang was also fined $ 10,000 for his acceptance of illegal gratuities from generic drug manufacturers. Chang resigned his position as a supervisory chemist in late April, several weeks after the criminal informations were filed against him. The U.S. Attorney's Office in Baltimore had sought a jail term for Chang. Assistant U.S. Attorney Gary Jordon, the prosecuting attorney for the case, characterized Chang's illegal conduct as "clearly . . . more extensive" than any of his colleagues at FDA. However, Jordon noted that the former FDAer's illegal activities should be balanced against his cooperation in the case. Overall, Chang received almost $ 78,000 in illegal gratuities from generic companies: $ 23,000 in cash from former Quad CEO Dilip Shah; $ 2,900 from former Par Senior VP Ashok Patel; $ 2,000 from former Pharmaceutical Basics exec Raj Matkari; $ 25,000 "in various benefits" from American Therapeutics; and over $ 25,000 in additional gratuities from undisclosed parties. The source and/or sources of the undisclosed gratuities are expected to be revealed as additional information counts or indictments are filed. Jordan noted that Chang agreed to plead guilty and cooperate in the investigation within two weeks of the July 18, 1988 search of his home. His cooperative efforts included taping a conversation with Matkari in which Chang got the PBI exec to make "certain admissions" relating to the $ 2,000 he gave the FDAer. Chang also engaged in a number of taped "undercover conversations" with Shah. Chang's defense attorney noted that at one point during the taped conversations Shah offered to send Chang's son to college. Chang also visited Shah in Indianapolis wearing a hidden microphone and attempted to get the exec to admit to giving illegal gifts. Shah reportedly discovered that Chang was wearing a wire while driving him back to the airport. Highlighting the extent of Chang's cooperation, the defense attorney noted that the FDAer became "panic stricken" when he lost sight of the agents that were following them and leapt out of the car while it was still moving. The defense attorney also asked the court to consider Chang's poor health and the personal circumstances that led to his acceptance of gifts. The lawyer noted that Chang's wife had left him roughly four years ago and that accepting illegal gratuities was Chang's way "of punishing himself" for his personal situation. In asking for a sentence to a half-way house, the defense attorney also noted that Chang, who is 47, had recently suffered a heart attack, perhaps as a result of his "internalization of what he's done." Chang is currently working part time as a pharmacist's assistant. Hargrove, in sentencing Chang, noted that he was taking the former FDAer's health into consideration. However, the judge again noted that in sentencing Chang he was setting an example for other government employees who might consider accepting gratuities for favors. Judge Hargrove declared that "one bad apple . . . will spoil the whole bunch," and that the "potential was tremendous for injury to the public." The judge observed that there is no evidence to date that Chang did anything that would permit unsafe drugs to come on the market.

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

Latest Headlines
See All
UsernamePublicRestriction

Register

PS016352

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

Cancel