There may be another <"https://www.yourlawyer.com/practice_areas/defective_drugs">drug approval scandal brewing at the Food & Drug Administration (FDA). Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, is facing charges from generics firm, Amphastar, that she showed favoritism to one of its competitor, a conflict of interest, said PharmExec. An official ethics complaint was filed.
In 2003, Amphastar submitted an application for approval of is generic version of Levenox, a blood-thinner, said PharmExec. Four years later, in 2007, the FDA rejected the drug citing immunogenicity concerns. But, following a review of public records, the firm found a conflict between the director and its rival, Momenta Pharmaceuticals, said PharmExec. Momenta filed for a similar blood thinner two years after Levenox, said PharmExec.
“It appeared [that] one of the founders of Momenta and the vice president of Sandoz, in February of 2007, were working together to define the immunogenicity standards at MIT,†Amphastar spokesperson Dan Dichner told PharmaExec. “They sent these emails to Janet Woodcock urging FDA not to approve a generic equivalent hastily.†Amphastar also claimed that when the heparin crisis occurred, Woodcock asked Momenta to identify the heparin contaminant and did not use its internal labs. Both Momenta and Amphastar produce blood thinners that include Heparin; neither firm was implicated in the contamination, said PharmaExec.
In addition, it was also determined that Woodcock wrote journal articles with Momenta scientists, which, claimed Amphastar, helped to raise the price of Momenta’s stock, said PharmaExec.
The FDA has long been the subject of criticism and earlier this year we wrote that many agency critics have complained of the corruption, conflicts of interest, and budgeting and system problems that appeared to be routine at the FDA under the former administration. In January, following President Barack Obama’s entry into the White House, one of the FDA’s most outspoken critics contributed to a public opinion piece geared to the new president on what he “needs to do to move beyond the Bush legacy,†said WebMD’s The Heart, quoting Nature.
Finally, following months of criticism, the FDA’s head of medical devices announced his resignation this week. In a letter, which was obtained by the Associated Press (AP) and sent to agency staffers, Daniel Schultz said he and FDA Commissioner Margaret Hamburg agreed his resignation “would be in the best interest of the center and the agency.†Schultz managed the division for five years, said the AP.
As we have previously written and the AP also just noted, scientists under Schultz’s claimed, “they were pressured to approve certain products†against their best judgment. In one stunning example cited by the AP, between 2006 and 2008, even though agency scientists rejected a Regen Biologics knee repair device on a number of occasions Schultz approved it in 2008.
Earlier this year, some FDA scientists wrote to President Obama’s transition team basically begging for help and outlining a number of problems with an agency they described as “fundamentally broken,†reported The Wall Street Journal previously.
