Last week, The House Committee on Energy and Commerce, Subcommittee on Health held a hearing on “Drug Safety: An Update from the Food and Drug Administration.” Many of the members of the Committee were present to hear the testimony of Joshua M. Sharfstein, M.D., Principal Deputy Commissioner, Food and Drug Administration (FDA).
Chairman of the Subcommittee, Congressman Pallone (D-NJ) opened the hearing by noting that in 2006 a series of safety problems with several approved drugs prompted the Institute of Medicine (IOM) and the Government Accountability Office (GAO) to examine the FDA’s post-market surveillance system. After conducting their review, IOM and GAO concluded that FDA needed more resources and more legal authority to better protect Americans from unsafe drugs.
These resources and legal authority came in the form the Food and Drug Administration Amendments Act of 2007 (FDAAA), which strengthened FDA’s post-market drug safety oversight. This legislation gave FDA the ability, for the first time, to require manufacturers to conduct post-market drug safety studies, and to make safety related changes to drug labels. Additionally, FDAAA gave the agency the ability to require a Risk Evaluation Mitigation Strategy (REMS) for drugs and biologics to ensure that the benefits of a drug or biologic outweigh its risks. FDAAA also provided FDA with certain tools related to drug advertising, such as requiring manufacturers to submit television advertisements to the agency for review prior to launching those ads. Lastly, FDAAA gave the agency enforcement tools, including the authority to impose civil monetary penalties for certain violations of the Federal Food, Drug, and Cosmetic Act with respect to drugs.
Since the amendments, FDA has required that sponsors conduct around 200 post-marketing studies or trials, and FDA has used its new authorities to require safety label changes in individual or classes of drugs 32 times since March 25, 2008.
Hearing
Members of the Committee asked for updates on REMS, and discussed why the FDA needs more authorities and more resources to do a better job policing the safety of imported products. Committee members also seemed to use the hearing to announce legislation, such as Representative Dingell’s (D-MI) Drug Administration Globalization Act of 2009 (H.R. 759), and Representative Buyer’s (R-IN) Safeguarding America’s Pharmaceuticals Act. This legislation, which is co-sponsored by Representative Matheson (D-UT) seeks to stop counterfeit, adulterated, or misbranded medicines from entering into this country.
Sharfstein’s testimony focused on two important issues: import safety and the implementation of the drug safety authorities in FDAAA
Testimony
Sharfstein began his testimony by noting that today there are an estimated 20 million shipments of FDA-regulated imports coming into the country each year. This breaks down to 40 percent of drugs being imported and 80 percent of pharmaceutical ingredients in drugs coming from foreign sources. This kind of growth has made it extremely complex, and as a result, Sharfstein stated that “FDA must adopt a new approach— one that addresses product safety by preventing problems at every point along the global supply chain, from the raw ingredient through production and distribution, all the way to U.S. consumers.”
Part of this new approach includes FDA seeking better controls at the point of production, and moving from an approach based on reacting to problems to one that proactively prevents such problems from ever occurring. Besides having various permanent FDA offices in countries like China, India, Costa Rica, and Mexico City, to name a few, FDA also has more than 30 agreements with foreign counterparts to share inspection reports and other nonpublic information that can help the FDA make better decisions about the safety of foreign products.
Another way FDA is addressing product safety is by working with industry to help them strengthen the safety of their supply chains. Sharfstein acknowledged how “some companies today already do a terrific job” demonstrating that safety, quality, and compliance with international and U.S. standards are built into every component of every product and every step of the production process. He also noted how some companies he has met with “react with incredible swiftness to questions about the integrity of their supply chain.” It is also important to recognize that these companies have a vital interest in ensuring confidence in the safety and quality of their products and their brand.
Although companies are moving in the right direct, Sharfstein explained that FDA needs additional tools to move oversight capabilities into the 21st century, and the agency needs to access regulatory information quickly, hold all parties responsible for the quality of products in the supply chain, and have reasonable and reliable options for enforcement. These new tools are important not only to ensure safety, but to make sure that regulations are not unduly burdensome on patient access to the drug.
REMS are crucial because they are designed to provide critical information to clinicians without unduly restricting access to the drugs, and they are also essential for maintaining patient access to important medications. Since 2007, 80 to 90 REMS have been approved. As a result, Sharfstein noted that “it is important to work with drug manufacturing companies to see what works best before moving forward,” and also to find to fast track the REMS process.
One issue affecting the REMS process was filling positions because of the current conflict of interest laws. Representative Shimkus asked if Congress needs to relax these laws so FDA has the most qualified expertise. In response, Sharfstein stated that this issue requires a balance “the agency needs to receive the best advice.”
FDA is planning to hold a public meeting to hear from prescribers, pharmacists, distributors, and payers about their roles in implementing REMS and from patient groups about the effects of REMS on access to needed products.
Sharfstein further added that the agency does not have adequate resources to prevent another problem like Heparin, and does not have enough resources to oversee all of the pharmaceutical drugs entering the country. The agency is also facing a back log for generic drug applications because have a different application and review process. Additionally, Sharfstein asserted that the FDA would like to receive more applications so more Americans can have access to these life saving drugs.
Sharfstein also discussed the Sentinel System, which was launched in May 2008 to enable the FDA to actively gather information about the postmarket safety and performance of its regulated products. He also talked about the FDA issuing a guidance in the near future for establishing a unique identification for prescription drug packages to help secure America’s drug supply. Sharfstein also discussed FDA’s new Safe Use Initiative, a program that will help with preventable harm by working with hospitals, nurses, and patient groups to recognize and mitigate risks.
Conclusion
As Representative Shimkus and Sharfstein both agreed, companies that take the risk of producing these life saving drugs should have an exclusive right to market the drugs for a period of time. Ensuring such protections in coordination with the new authority FDA have been given will allow new treatments and innovations to continue. Moreover, the authority to require REMS provides FDA a very useful set of tools that can be used to reduce the risks of marketed products, while allowing patients to benefit from lifesaving and other beneficial treatments that could not be safely marketed without a risk management program. The progress that FDA has made thus far should only be enhanced by more resources and funding to continue the agency’s ability to allow patients to benefit from these innovations.