Hamburg's most high profile initiative is to streamline the process for issuing warning letters and for taking enforcement
actions against manufacturers that violate good manufacturing practices (GMPs) and other agency rules. Many serious violations
"have gone unaddressed for far too long," including manufacturing problems, product adulteration, and false and misleading
labeling and advertising, Hamburg commented at an August meeting sponsored by the Food and Drug Law Institute. The commissioner
wants to limit all the back-and-forth wrangling with regulated companies that delays compliance and says the FDA will implement
recalls or seizures if serious health and safety issues are not corrected promptly.
Under the new program, a manufacturer has 15 working days after receiving a 483 inspection report to head off a warning letter
or other regulatory action by providing information on how it will address cited violations. The FDA also aims to issue warning
letters more promptly by ending the extra internal legal review of such documents before they are sent out. The Bush administration
requirement that the FDA chief counsel examine all proposed warning letters, "created very cumbersome practices without a
lot of benefit," observed Hamburg. Now the chief counsel will review only those proposed warning letters that raise "novel,
complex, and sensitive issues," such as an activity involved in a lawsuit or recently established by legislation.
On its part, the FDA hopes to encourage fast industry corrective action by promptly reinspecting or re-evaluating a company's
remedial efforts. So that manufacturers are not left wondering if a corrective action is adequate, the FDA will issue a formal
close-out letter and post it on its web site, providing manufacturers with an official statement to show investors and customers
that they're back in the FDA's good graces, and that a facility or product is no longer tainted by quality or safety issues.
But if reinspection reveals that cited problems are not corrected, FDA says it won't just issue another warning letter, but
may initiate seizures, closures, or take other regulatory action.
Even before announcing these changes, FDA officials were stepping up GMP enforcement and publicizing warning letters. In June,
Genzyme had to shut down its facility in Allston Landing, MA because of viral contamination, leading to serious shortages
of enzyme replacement therapies such as Cerezyme (imiglucerase). A threat to revoke Immucor's biologics license for poor quality
control of blood diagnostic products prompted fast development of a corporate remediation plan and quality process improvements.
Hamburg expects an increase in warning letters initially, but anticipates that the volume will level off as industry recognizes
that a strong compliance program is good for business and for consumers. The FDA's success in spurring compliance "should
be measured not by the number of warning letters or injunctions or seizures," she said, but by "our impact on the health and
welfare of the public." Failure to meet FDA standards means that a company is "putting the public at risk" and also "jeopardizing
the public's confidence in your industry." Alternatively, speedy corrective efforts by companies and broader compliance throughout
the industry will increase public confidence in the FDA and better educate consumers about potential risks in medical products.
Jill Wechsler is BioPharm International's Washington editor, Chevy Chase, MD, 301.656.4634, email@example.com