In 2006, Senator Charles E. Grassley raised concerns regarding the FDA’s postmarket drug safety program. In particular, Senator Grassley mentioned that the FDA was slow to inform doctors of links between drugs and dangerous side effects, examples included the association between antidepressants and suicidal behavior as well as Vioxx and cardiovascular risks.
The FDA has two offices that are involved in postmarket drug safety activities: The Office of New Drugs (“OND”) and the Office of Drug Safety (“ODS”). OND is responsible for approving drugs and takes regulatory actions regarding the postmarketing safety of drugs. ODS is a consultant to OND and doesn’t have independent decision making abilities. Senator Grassley’s report found that there has been a high turnover of ODS directors and that the “FDA lacks a clear and effective process for making decisions about, and providing management oversight of, postmarketing drug safety issues.”
Most importantly, the report found that the FDA has the authority to withdraw the approval of a drug on the market but rarely does so, citing 10 withdrawals for safety reasons since 2000. This is due, in part, because of the limited authority that the FDA has to required manufacturers to perform premarket studies. The report concluded that the FDA can only improve if it is able to obtain data from long-term clinical trials of certain drugs and carry the authority to require that these clinical studies be conducted.
Despite the publication of this report in 2006, it was found that in 2009, the FDA continued to struggle with its postmarketing duties. For example, it was found that the FDA was severely understaffed and unable to review promotion material submitted by drug companies and was suffering from “critical staff shortages.”
In 2006 alone, medical products generated $290 billion in sales and 3.3 billion prescriptions were filled. This astounding number demonstrates that the role of the FDA has evolved with an ever growing number of drugs waiting to be approved, the FDA simply does not have the staff to keep up. Even Rita Chappelle, an FDA spokeswoman recently said to Bloomberg, “while we have hired extensively this year, there is a long, steep learning curve for new review staff so we can’t expect that their arrival will immediately translate into improvement in the impact of workload.”
While the FDA is quickly trying to improve its postmarketing and drug application review programs, what remains certain is that patient safety remains a major concern among legislators and healthcare professionals. For more information regarding pharmaceutical and medical device cases, please contact us. We have obtained millions of dollars in verdicts and settlements for our clients.