R.D. McDowall
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The Food and Drug Administration (FDA) has not had good press over the last few years, as they have been on the receiving
end of two critical reports from the Government Audit Office (GAO). The last report covered the FDA foreign inspection program
and was damning in the fact that the FDA does not know how many establishments it has to inspect, relies upon volunteers to
inspect overseas, and when they do conduct inspections, the frequency is lower than in the U.S. (1).
FDA Modernization Act 2009
As a result of this report and also the increased threat of supply chain contamination, the FDA Modernization Act 2009 (2)
is being passed into law and covers the following areas:
- Creates an up-to-date registry of all drug and device facilities serving American consumers.
- Increases funding for more GMP inspections for ethical and generic drugs as well as introduces preapproval inspections for
generic drugs.
- Requires parity between foreign and domestic inspections, and to meet this, the FDA is setting up offices in China, India,
Europe, and Latin America.
- Denies entry to drugs coming from facilities that limit, delay, or deny FDA inspections.
- Requires manufacturers to know their supply chain including the identification and mitigation of risk throughout their supply
chain.
- Requires country-of-origin labeling for components.
Concomitantly, there also has been an increase in budget to fund this and increase the inspection program. So what does that
mean for me in the laboratory? This stuff appears to be too high a level to even contemplate doing anything about. What's
this about a tiger and new teeth? It may seem that the tiger has been stuffed but the good bits start in the next section.
New FDA Commissioner Acts
In addition to the FDA Modernization Act 2009, there also has been a change at the top with the appointment of Dr. Margaret
Hamburg as the new FDA commissioner in May 2009. On August 6, 2009, the new commissioner made a speech that emphasized the
need for a "strong FDA," which highlighted the benefits of this new approach as having credibility with the public, being
transparent in explaining its decisions, being able to enforce the law, and being creative in promoting health. In this speech,
with an accompanying video (3), were such quotations as
- "Through regular inspections and follow-up on signals indicating problems, the FDA must work to identify and resolve problems
early."
- "Companies must have a realistic expectation that if they are crossing the line, they will be caught, and that if they fail
to act, we will."
- "The agency must show industry and consumers that we are on the job. We must publicize our enforcement actions — and the rationale
for those actions — widely and effectively."
- "The agency must place greater emphasis on significant risks and violations, and use meaningful penalties to send a strong
message to discourage future offenses."
The strong message coming through loud and clear is be compliant and remain compliant with the regulations — or else. You'll
now see that the tiger, far from being ready for the taxidermist, is starting to sharpen its teeth.
Not only does this apply to the here-and-now but also, as noted in the final bullet point, the commissioner wants to discourage
future offences. So why change the FDA approach to enforcement? One of the rationales for this was mentioned in the speech
as the pathways for enforcement action can be too long and arduous when the public's health is in jeopardy. So from this and
the FDA, we must infer that the FDA will be increasing inspections while tightening up and speeding up enforcement actions.
Thus. it was not surprising that the FDA announced in the Federal Register of August 11 (4) the trial of a new program entitled "Review of Post-Inspection Responses." The purpose of this program is
to facilitate the timely issuance of warning letters that started on September 15, 2009 and will run for 18 months (the tiger
has just come back from the dentist and is feeling hungry — are you getting the message?).
