We all depend on the US Food and Drug Administration to enforce standards that keep our drugs safe. We expect the agency to set clear guidelines for consumers and manufacturers to follow. We also assume that the agency has standards for its own activities and ways of ensuring that agents comply with those standards. Unfortunately, a recent report from the US Government Accountability Office (GAO) shows that FDA has not entirely lived up to our expectations. Read more »

News reports about adulterated drugs seem to have been replaced by stories of contaminated food products. Cases of salmonella related to products that contain peanuts and pistachios are the latest examples. The US Food and Drug Administration has been blamed for failing to protect consumers, and commentators have cited outdated policies, inadequate staffing, and insufficient funds.

In February 2009, Rep. Rosa DeLauro (D-CT) proposed creating a separate Food Safety Administration to improve oversight of food products sold in the United States. But a recent FDA Warning Letter suggests that drawing a line between food and drug products might not be so simple. Read more »

Perhaps out of embarrassment at the stream of incidents involving contaminated products, the US Food and Drug Administration has requested the largest budget increase in its history. The agency intends to use part of the funds for its proposed Safer Medical Products initiative, which will scrutinize domestic and imported drugs. Will it use the money wisely? Read more »

“The Physician Payments Sunshine Act” (see my previous post), introduced by Senators Chuck Grassley (R-IA) and Herb Kohl (D-WI), would require drug companies to disclose their payments to physicians. Besides showing how the pharmaceutical industry can influence the way doctors practice medicine, the act would also illustrate how industry payments might influence university research about drugs. Read more »

FDA needs drastic changes to its policies and operations, according to Rep. John Dingell (D-MI) and Sen. Chuck Grassley (R-IA), who have developed a plan to revamp the agency. Restructuring FDA’s power and giving it the ability to recall drugs, impose fines, and regulate drug advertising are among the changes proposed by Dingell and Grassley, as outlined in a report by the Wall Street Journal (WSJ) yesterday. They also believe the agency is “too cozy” with pharmaceutical companies and are calling for the next president to appoint a commissioner with no ties to industry. Read more »

Success can be a mixed blessing, as the pharmaceutical industry well knows. Drug companies have prospered by developing and marketing new medicines that improve patients’ lives. But the industry’s impressive profits also bring public scrutiny and criticism. Sometimes the criticism is warranted, sometimes it’s unwarranted. Read more »

According to the dictionary, “transparent” means “free of deceit,” “easily understood or seen through (because of a lack of subtlety).” In this election year, the term is popping up on almost every radio and talk show. Just as transparency is deemed a value among politicians, it is also expected from businesses, and the pharmaceutical business is no different. Read more »