FDA Took Tougher Stance in 2009

Earlier last year we wrote that many critics of the U.S. Food and Drug Administration (FDA) had long complained of food and <“https://www.yourlawyer.com/practice_areas/defective_drugs”>drug safety problems, corruption, conflicts of interest, and budgeting and system problems that appeared to be routine at the agency under the former administration. With the Obama administration, new leaders were put in place and safety became an issue of importance at the FDA.

According to the Associated Press (AP), despite the new focus, drug approvals saw little change; warnings issued by the agency dropped; so-called “first-of-a-kind” prescription drug approvals increased; and revised or new “black-box” warnings fell. But, under the new administration, the agency did increase its “early communications”; expanded enforcement of fake or dangerous products; and managed bogus swine flu remedies, defective nasal sprays, and steroid-containing supplements, said the FDA.

Some scientists at the FDA wrote to President Obama’s transition team earlier last year, basically begging for help and outlining a number of problems with an agency they described as “fundamentally broken,” reported The Wall Street Journal previously. Dr. Steven Nissen, a prominent cardiologist with the renowned Cleveland Clinic in Ohio, was one of those who offered opinions. In his piece, said TheHeart, Dr. Nissen called for “’an end to secrecy,’ to ‘revive’” the agency.

As we have previously written and the AP noted last year, scientists under former medical device head, Daniel Schultz, claimed, “they were pressured to approve certain products” against their best judgment. It was the nine-scientist letter that added to the call for reform at the agency. Following the letter, a number of lawmakers—such as Representative Henry Waxman (Democrat-California) and Senator Chuck Grassley (Republican-Iowa)—called on the FDA to investigate the alleged corruption, reported the AP. Schultz ultimately resigned saying, with Hamburg, that his resignation “would be in the best interest of the center and the agency.” Schultz managed the division for five years, said the AP.

Under President Barack Obama’s administration, Dr. Margaret Hamburg was brought in as the agency’s commissioner and Dr. Joshua Sharfstein was brought in as deputy commissioner. Analysts say that the agency has strengthened with its new regime, which enables it to move more effectively, said the AP. “A strong FDA is good for regulated industry,” said Ira Loss, quoted the AP. “Sharfstein and Hamburg bring confidence and certainty to an agency that was badly in need of it, and the rank-and-file staffers are now able to move with confidence that the agency has their back,” Loss added, quoted the AP, which noted that Loss is an analyst with Washington Analysis which has covered the agency for 30 years.

The issue with drug review has also been addressed, said the AP. A staffing dearth two years ago led to easing up of review deadlines. Now, the hiring boom has improved review timing with estimates at 85-percent on-time review processing, close to the 90-percent goal the agency is seeking, explained the AP.

Unfortunately, with the increase in new full-time positions—about 760—a lot of the newly-hired reviewers have less experience, an issue that the agency believes will improve over time, reported the AP.