The headlines about contaminated heparin and tainted peanuts have put pressure on FDA to improve its methods for detecting unsafe medical and food products and to take swift action when problems emerge. The complaints are prompting the Obama administration to provide more resources for FDA while Congress weighs expanding agency operations and enforcement authority.
The headlines about contaminated heparin and tainted peanuts have put pressure on FDA to improve its methods for detecting unsafe medical and food products and to take swift action when problems emerge. In February, President Barack Obama criticized FDA's ineptitude in catching contaminated products and urged a "complete review of FDA operations." The Government Accountability Office put FDA on its federal agency "high-risk" list in January because of its failure to protect public health and ensure the safety of drugs, biologics, and medical devices. The complaints are prompting the Obama administration to provide more resources for FDA while Congress weighs expanding agency operations and enforcement authority.
One positive sign is the White House's move to install a new FDA commissioner as soon as possible, instead of waiting until Kansas Governor Kathleen Sebelius is confirmed as Health and Human Services (HHS) Secretary. Last month, during a talk on food-safety failures, President Obama announced the selection of Margaret Hamburg, MD, to lead FDA, along with Joshua Sharfstein, MD, as principal deputy commissioner.
Hamburg appears to many to be a good choice for the job. She has experience with turning around a demoralized, underfunded public health agency, having served as New York City's public health commissioner in the 1990s. Before that, she performed AIDS research at the National Institutes of Health (NIH) and headed up the HHS policy office during the Clinton administration. Recently she has led the Nuclear Threat Initiative's effort to reduce the threat of biological weapons. Representatives of industry and consumer groups alike have applauded Hamburg as capable and experienced in running a large health agency.
In addition to naming new officials, the White House pledged to further beef up funding for FDA food inspections and to modernize agency laboratories. This comes on the heels of FDA receiving a record $2.6 billion budget for fiscal year 2009, including user fees, which was finally approved by Congress last month amid cheers from the Alliance for a Stronger FDA and other agency advocates. The total includes more than $2 billion from the government, a $325 million increase over 2008.
FDA receives $413 million in appropriated funds for drugs and $184 million for biologics this year; user fees add $500 million for a total of $1 billion for pharmaceutical oversight. That specifically includes $41 million for the Office of Generic Drugs, $16 million to support the agency's Critical Path Initiative, and $6.6 million to enhance the review of direct-to-consumer drug advertising.
Possibly the biggest challenge for FDA's new commissioner will be to make the case for increases in funding, which will require a clear sense of where the agency is headed and how it will get there. And it remains to be seen whether the appointment of two high-profile officials to share FDA leadership will really work.
FDA is slated to receive even more resources to boost food and drug inspections under the FDA Globalization Act of 2009 (HR 759), a priority initiative for Rep. John Dingell (D–Mich), former chairman of the House Energy & Commerce Committee. Co-sponsor Frank Pallone (D–NJ), head of the Energy & Commerce Health subcommittee, says he plans to hold hearings on the legislation and to move it through committee simultaneously with health reform proposals.
The Globalization Act expands FDA's authority to inspect foreign plants, to block questionable imports, and to crack down on those who fail to comply. Regulatory "parity" is sought to ensure that lax oversight is not luring manufacturers from the United States to Asia. All registered manufacturers and importers-including generic drugmakers-will have to pay new user fees to support the broader oversight program, and manufacturers will ensure the integrity of product supply chains through electronic pedigrees. FDA also would gain the power to detain, recall, or destroy unsafe, adulterated, or misbranded goods. The act gives the agency added authority to subpoena records and to impose criminal penalties for drug counterfeiting.
Ironically, legislation that increases FDA inspections of foreign drugmakers may reopen the door to drug importing. A group of leading senators is sponsoring a bill to allow nationwide reimportation of prescription drugs, claiming that the program would save $50 billion over 10 years. All of the imports would have to come from FDA-approved manufacturing plants in Canada, Europe, Australia, New Zealand, and Japan-a policy that assumes more frequent inspections and a viable pedigree system.
Energy & Commerce Chairman Waxman is rolling out a number of bills to reshape FDA operations and drug regulation. A top priority is legislation to put tobacco marketing under FDA control. This measure has been approved at different times in both the House and Senate and could move through Congress quickly. Philip Morris and anti-tobacco advocacy groups back the measure, whereas smaller tobacco companies oppose it. Some public health groups complain that the measure doesn't go far enough, but some medical product makers fear that tobacco oversight will be a huge burden on an already overloaded agency.
Also back on the front burner is the issue of follow-on biologics, with Waxman sponsoring a new legislative proposal that features a very low five-year period of exclusivity, with the possibility of short extensions. The bill establishes a process for early resolution of patent disputes and gives FDA authority to collect user fees from biosimilar applicants and to determine what clinical trials and postmarket studies are needed for interchangeable "biogeneric" products as well as for regular biosimilars. Many generics makers, pharmacy benefit managers, payors, and consumer groups cheered the prospect of lower-cost biotech therapies; the National Organization for Rare Disorders backed the bill as one that was likely to help patients afford lifesaving therapies and to stimulate competition even more.
Pharmaceutical and biotech companies, however, objected that Waxman's proposal would jeopardize R&D into vital new therapies. Industry instead backs another bipartisan House bill that provides 12 years of data exclusivity, with another two years possible. FDA would have to issue guidance on what evidence is needed to approve a biosimilar, and interchangeability would be more difficult to document.
SUPPORT FOR STEM-CELL RESEARCH
Another issue before Congress is legislation to further reduce restrictions on embryonic stem-cell research. The executive order recently signed by President Obama does not eliminate an earlier legislative ban on federal funding of stem-cell line development that involves destroying embryos. The presidential action permits government support only of research involving new, privately funded embryonic cell lines, which researchers say are healthier and more varied than the few old lines available for research under the Bush administration policy. It is still up to Congress to reverse the earlier restrictions; nonetheless, such proposals raise objections from many conservatives that government support will lead to embryo harvesting and even human cloning.
In the meantime, the NIH is charged with developing guidelines to implement the presidential order. The main issue is whether to fund only studies that use "spare" embryos left over from infertility treatments, or also to fund research involving embryonic stem cells produced specifically for R&D purposes. Many biotech companies praised the presidential order as likely to further development of cell-based therapies leading to cures for cancer, diabetes, and spinal cord injuries, as well as Alzheimer's and Parkinson's diseases. One possible consequence of the new policy, however, is that increased federal support for stem-cell research may dry up funding for state initiatives in this area.
In a memo accompanying the stem-cell research policy, President Obama stated that scientific integrity should shape federal debate on biomedical research, as well as on energy policy, climate change, and other scientific endeavors. He directed federal agencies to develop guidelines and to pick science advisers on the basis of expertise, rather than political ideology. The aim is to avoid any repetition of charges that the Bush White House distorted or suppressed scientific information that ran counter to administration values. Delayed approval of an over-the-counter version of the morning-after pill, for example, resulted in controversy wracking FDA for months-and it is doing so still.
However, the line between politics and science is often fuzzy, whether the subject is embryo research or climate change. Many conservatives protested the appointment of Harvard University professor John Holdren as head of the White House Office of Science and Technology Policy, citing his strong support for initiatives to prevent global warming. One party's sound science often is another's political agenda.
Ms Wechsler is a Washington-based reporter specializing in federal and state healthcare issues.