Claris Law Legal Blogging Community

Editor: Robert Blanchard
Profession: Attorney at Law

Category: Ortho Evra Warnings

Fascinating that even though the new warning for Ortho Evra birth control patche clearly states that the patch use results in getting 60% more estrogen than expected, the product is still on the market! Women are still wearing what can now only be considered a dangerous product. The danger of such high doses of estrogen was established years ago for oral contraceptives and the FDA required lower doses for the Pill. Why hasn't the same been done for the patch? Some Republicans on the payroll no doubt. Look for the news articles on Bush's last FDA appointment now being charged with accepting bribes. See link.

From the Chicago Sun Times - The former commissioner of the Food and Drug Administration is under federal investigation amid accusations of financial improprieties and making false statements to Congress, a newspaper reported Saturday.

The New York Times, citing attorney Barbara Van Gelder, said a grand jury has begun a criminal investigation of Lester Crawford. She declined further comment.

Van Gelder told a federal magistrate in a telephone hearing Thursday that she would instruct Crawford to invoke his Fifth Amendment right against self-incrimination if ordered to answer questions about his actions as head of the FDA, a transcript of the hearing shows.

Crawford did not reply to messages left by the Times. Messages left Saturday at Crawford's home and Van Gelder's office in Washington were not returned.

Crawford resigned in September, two months after the Senate confirmed him, saying it was time for someone else to lead the agency. He had been acting commissioner for more than a year.

A month before he resigned, Crawford sold more than $50,000 in shares in a company regulated by the agency, financial disclosure forms show.

The criminal investigation was disclosed at a court hearing in a lawsuit over the FDA's actions on emergency contraceptive pills, a subject of dispute during Crawford's tenure.

After the pill's maker, Barr Laboratories, applied three years ago to sell Plan B over the counter, the agency repeatedly delayed a decision on its application.

Many lawmakers, abortion rights advocates and former FDA officials said the delays had resulted from politics, but Crawford and other agency officials said their concerns were scientific and legal.

The Center for Reproductive Rights sued the agency in federal court in New York over the delays. A judge allowed the case to proceed, giving the center the right to interview top FDA officials, including Crawford.