Contaminated peanut butter, syringes filled with tainted heparin, drugs from India with fraudulent laboratory tests, and other
manufacturing and quality-control crises are spurring efforts to overhaul US Food and Drug Administration programs and policies.
In February 2009, President Barack Obama criticized FDA's inability to catch contaminated products and urged a "complete review
of FDA operations." The Government Accountability Office (GAO) put FDA on its federal agency "high-risk" list in January 2009,
citing a need to improve its data on manufacturing facilities and to conduct more foreign inspections.
Instead of just blasting the agency, though, the Obama administration is providing added resources to enhance FDA's oversight
of product safety. Congress finally approved legislation in March 2009 to appropriate funding for the government's 2009 fiscal
year, which began in October 2008. The bill gives FDA more than $2 billion in appropriated funds, a $325 million increase
over 2008. After adding in user fees, the agency will have a record $2.6 billion budget. The Alliance for a Stronger FDA cheered
this "important down payment" to meet pressing agency needs. Whether FDA's budget continues to increase remains to be seen
as the Obama administration rolls out details of its FY 2010 budget.
The FY 2009 budget includes $413 million for drugs and $184 million for biologics. User fees add $500 million to provide a
total of $1 billion for drug oversight. That includes $41 million set aside 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.
Congress wants to keep a close watch on how FDA uses these significant funding increases to enhance food and medical product
safety and has requested detailed quarterly reports on new hires, inspections, and technology acquisitions. The legislators
expect a significant increase in foreign and domestic facility inspections, expansion of laboratory infrastructure, upgrades
in agency information technology, and improved electronic screening of imports based on integrated risk-based information
systems. Congressional leaders also urge active initiatives to prevent product contamination, including conducting compliance
audits of food producers and foreign drug facilities to gain a better understanding of risks and how to address them.
FDA is slated to receive even more resources to boost foreign drug inspections under the FDA Globalization Act of 2009 (HR
759), a priority initiative for Rep. John Dingell (D-MI). Main cosponsors include Rep. Frank Pallone (D-NJ), head of the House
Energy and Commerce Committee (E&C) Health subcommittee, and Rep. Bart Stupak (D-CO), chair of the E&C Oversight subcommittee,
who has been investigating FDA import and inspection failings for several years. Pallone plans to hold hearings on the legislation
and move it through committee simultaneously with health-reform measures.
In Washington This Month
The Globalization Act would authorize FDA to inspect foreign drug manufacturers every two years, block questionable imports,
and crack down on those who fail to comply. Regulatory parity is sought to ensure that lax oversight and fewer overseas inspections
are not a reason for manufacturers to shift operations from the US 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 ePedigrees. Current law requires FDA to inspect drug manufacturers every two
years, but the agency has never had sufficient resources to do so. The legislation aims to avoid that dilemma by establishing
a detailed process for FDA to calculate fees every year to meet program costs.