Jill Wechsler
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All the headlines about contaminated syringes and tainted peanuts have put pressure on the US Food and Drug Administration
to better detect unsafe medical and food products and to take swift action when problems emerge. In February, President Barack
Obama criticized the FDA's ineptness in catching contaminated products and urged a "complete review of FDA operations." The
Government Accountability Office (GAO) put the 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
White House to provide more resources for the FDA while Congress weighs a number of proposals for expanding foreign inspections
and giving the agency more enforcement authority.
One positive sign is the boost in the FDA's budget to enhance oversight of food and medical product safety. In the long-delayed
2009 federal appropriations bill, the FDA received more than $2 billion from the government, a $325 million increase over
2008. After adding in user fees, the agency will have a record $2.6 billion budget. That includes $413 million for drugs and
$184 million for biologics, plus $500 million in user fees. In return, the legislators expect a significant increase in foreign
and domestic facility inspections, expansion of laboratory infrastructure, and upgrades in information technology. The Alliance
for a Stronger FDA cheered the funding increase and will press to continue the trend as the Obama administration rolls out
details of its 2010 funding plan.
GLOBAL OVERSIGHT
The FDA is slated to receive even more resources to boost inspections under the FDA Globalization Act of 2009 (HR 759), a
priority initiative for Rep. John Dingell (D-MI), former chairman of the House Energy & Commerce Committee. Main co-sponsors
include Rep. Frank Pallone (D-NJ), head of the E&C Health subcommittee, and E&C Oversight subcommittee chair Rep. Bart Stupak
(D-CO), who has been investigating FDA import and inspection failings for several years. Pallone says he plans to hold hearings
on the legislation and to move it through the committee simultaneously with health-reform proposals.
The Globalization Act expands the FDA's authority to inspect foreign plants and 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
US to Asia. All registered manufacturers and importers—including generic drug makers—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.
The FDA also would gain the power to recall, destroy, or detain unsafe, adulterated, or misbranded goods. There is added authority
to subpoena records and to impose criminal penalties for drug counterfeiting. To improve its inspection program, the FDA is
instructed to establish a dedicated cadre of inspectors for foreign food and medical product facilities. And FDA officials
are prohibited from closing down field laboratories or district offices without making a case for such changes in a reorganization
plan that will be reviewed by GAO and submitted to Congress.
Of particular interest to biopharmaceutical companies is new language in the bill specifying that FDA policies do not override
state laws. This provision reflects Democratic opposition to FDA pre-emption of state liability laws, but may be less important
in wake of the recent Supreme Court ruling in the landmark Wyeth versus Levine case. Last month, the Justices rejected Wyeth's
claim that FDA approval of a drug's labeling overrides state laws and agreed with the plaintiff that FDA decisions are not
the last word in drug regulation. The Globalization Act supports this contention and opens the door for state prosecutors
and plaintiffs attorneys to bring actions against companies that violate state laws even though they comply with FDA regulations.
The revised Dingell bill addresses some concerns raised by the FDA and manufacturers to an earlier proposal. Instead of requiring
country-of-origin information on every ingredient in a product, for example, the FDA gains a year to develop rules for providing
this information to the public, possibly through web sites. There's noticeable support for risk-based approaches to ensuring
product quality and safety, plus flexibility for the FDA to reduce inspections from every two to every four years at plants
that produce low-risk therapies and that present a strong record of compliance with good manufacturing practices (GMPs). All
registered pharmaceutical manufacturing facilities will have to develop quality risk-management plans that spell out procedures
for auditing and qualifying raw ingredients and for monitoring incoming materials.
