Personal Injury Law

Obama Asked To Ensure a Clean Slate at the FDA

By Jim Clark

Bold assertions were made against the Food and Drug Admistration to President Obama in a letter written April 2, and most of the assertions do an excellent job at capturing the frustration of scientists, physicians, and the American people have with the decisions by FDA officials.

Over the last decade, the FDA has come under serious criticism for politically motivated policies and regulation. In 2006, the FDA regulated the 'Plan B' drug for women to be only accessible by those 18 and over. With little scientific finding to support this decision, the FDA acted arbitrarily in order to promote the political purpose of deterring sex at an early age. Whether a person agrees or disagrees with the reasoning, this arbitrary and politically-motivated decision goes against the FDA's mission statement, which is the promotion and advancement of human health. A federal judge in New York agreed with this finding, and ruled that the FDA overstepped its authority and sought to impose a capricious agenda on the American people.

The letter goes on to call out managers and attorneys within the FDA who, as the letter alleges, fostered this political ideology and censoring which has undermined the FDA's purpose. In one case, Dr. Donna-Bea Tillman approved a medical device used for the detection of breast cancer despite every FDA expert involved recommending against the approval (three times). This decision was made after a phone call between Dr. Tillman and congressman Christopher Shays. After this and another instance of wrongdoing was published, acting Commissioner Dr. Frank Torti and FDA attorneys sent out a company-wide e-mail instructing all employees to 'comply with… obligations to keep certain information … confidential … [including] e-mail to and from employees within [the] FDA [that document the] deliberative process.'

It remains to be seen what major policy changes will be made within the FDA, but if the allegations in this letter are true, things can't get much worse.

Full post as published by Tampa Bay Personal Injury Law on April 20, 2009 (boomark / email).