GAO Critical of FDA's Drug Review Process

Leaders with the Government Accounting Office hold that the agency needs to be more efficient and effective in processing applications.

While a new report from the Government Accountability Office (GAO) shows that the Food and Drug Administration (FDA) has become more efficient in terms of its overall processing and reviewing applications, it also found that three of the five consumer advocacy group stakeholders that GAO researchers spoke with raised issues about whether FDA is adequately ensuring the safety and efficacy of the drugs it approves for marketing. Those same stakeholders also said that FDA should place greater priority on safety and efficacy over review speed, and that FDA does not gather enough data on long-term drug safety and efficacy through methods such as postmarket surveillance. AIDS Healthcare Foundation (AHF), the nation's largest HIV/AIDS organization, heralded the report, dated March 30, 2012, but which was not made public until this week when it was first posted on the GAO website (see also HIV/AIDS).
"The screening of potentially unsafe food, drugs and medical products is-or should be-one of the most basic and trusted functions of our government," said Michael Weinstein, President of AIDS Healthcare Foundation. "However, this new GAO report, which polled two industry stakeholders and five consumer advocacy group stakeholders, raises serious questions about whether the FDA is properly ensuring the safety and efficacy of the drugs it approves and indicates that there is insufficient communication between the FDA and many stakeholders. Sadly, our own experience with the FDA over the past year suggests the observations in this report ring true."
AHF has been at odds with FDA officials over the past year after trying unsuccessfully to obtain information regarding a supplemental New Drug Application (sNDA) filed with FDA by Gilead Sciences seeking an expedited review of its application for use of its blockbuster once-daily AIDS treatment, Truvada (emtricitabine/tenofovir disoproxil fumarate) for use as a possible HIV prevention pill (known as 'Pre-Exposure Prophylaxis,' or 'PrEP'). Despite the fact that the drug failed to meet the agency's own guidelines for approving an expedited review, the FDA granted Gilead Sciences the expedited review in mid-February, and a hearing on Gilead's application is set for May 10th at FDA headquarters in Maryland.
Under the FDA Manual of Policies and Procedures, an expedited review is granted only if a drug meets certain criteria; it must have the potential to be a "[s]afe and effective therapy where no satisfactory alternative therapy exists," or "[a] significant improvement compared to marketed products, including nondrug products or therapies..." Truvada as PrEP does not meet this criteria. There are other safe and effective options available to HIV-negative (uninfected) individuals, such as condoms. In addition, condoms and treating positives, both of which reduce transmission by over 95%, are more effective than any study has demonstrated for PrEP.
Questions about PrEP's safety and effectiveness extend beyond its qualifications for expedited review. While some studies claim to show a limited preventive effect (only 44%), other studies have been halted because PrEP was not shown to be any more effective than a placebo at preventing HIV. Due to the likely scenario that the people who take PrEP will not be protected, it could lead to an increase in HIV infections and other sexually transmitted disease. In addition, the people who take PrEP are at an increased risk of developing a drug resistant strain of the HIV virus and kidney disease, even after they stop taking the drug. Background on AHF's Dealings with FDA In a response to an AHF lawsuit filed last year on FDA's refusal to disclose documents under the Freedom of Information Act (FOIA), FDA claimed that the "premise that FDA's review of a pending drug application should be transparent is also wrong," and that "FDA's drug review process is not a participatory process." The agency also asserted that "[t]he value of public participation in FDA's scientific review of a new drug application is particularly ambiguous ..."
"President Obama pledged that his administration would be the most transparent in history, yet on an issue of paramount importance to the health and safety of the American public, FDA claims that it does not have to be transparent, and that the American public has no voice on how FDA conducts their business," said Tom Myers, AHF General Counsel and Chief of Public Affairs at the time of the filing of the lawsuit. "One can only assume that the FDA is refusing to be transparent because it has something to hide."
Earlier this year, the Washington Post also reported that six of the FDA's own scientists sued the agency because "...the FDA secretly monitored the personal e-mail of a group of its own scientists and doctors after they warned Congress that the agency was approving medical devices that they believed posed unacceptable risks to patients."
"We simply cannot afford to wait for the health and safety of the American public to be put at further risk before taking action against the FDA and hold it accountable to honor its mission on behalf of the public," added AHF's Weinstein. AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to more than 166,000 individuals in 25 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Eastern Europe. To

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