Are you Ready for a Strong FDA?

Dec 01, 2009

There is a new US Food and Drug Administration (FDA) Commissioner who wants a "strong" FDA and she is backing her words with action by initiating a programme that cuts the time that firms must respond to 483 observations from 30 to 15 business days. Not only is the time halved but the response must also be complete! Be prepared to be compliant and remain compliant with regulations — or else.

There you are sitting at your desk browsing the latest copy of LCGC Europe wondering what the title of this column is all about. If you work in a regulated healthcare company that sells products to the USA or for a laboratory that works on behalf of these regulated companies you will know that FDA (Food and Drug Administration) inspectors inspect your company every so often. Occasionally an inspector may come into the chromatography laboratory and inspect the way that you work against the requirements of good manufacturing practice (GMP) or good laboratory practice (GLP). Prepare to be prepared when the FDA inspectors next pop in for tea and biscuits and a cosy chat. The FDA has changed its approach to inspections recently and chromatographers must understand the impact that this will have on your approach to regulatory compliance in the laboratory.

FDA Modernization Act 2009

The FDA has not had good press over the last few years and has been on the receiving end of two critical reports from the Government Audit Office (GAO). The last report covered the FDA foreign inspection programme1 and was damning in the fact that the FDA don't know how many establishments it has to inspect, relies on volunteers to inspect overseas and when they do conduct inspections the frequency is lower than in the US.

As a result of this report — and the increased threat of supply chain contamination — the FDA Modernization Act 2009 2 is being passed into law and will involve:

  • Creating an up-to-date registry of all drug and device facilities serving American consumers.
  • Increasing funding for more GMP inspections for ethical and generic drugs, as well as introducing pre-approval inspections for generic drugs.
  • Parity between foreign and domestic inspections. To meet this requirement the FDA are setting up offices in China, India, Europe and Latin America
  • Denying entry to drugs coming from facilities that limit, delay or deny FDA inspections.
  • Manufacturers knowing their supply chain, including the identification and mitigation of risk throughout their supply chain.
  • Establishing "Country of Origin" labelling for components.

Concomitantly there has also been an increase in budget to fund this and increase the inspection programme.

So what does that mean for me in the chromatography laboratory? This stuff appears to be too high a level to even contemplate doing anything about. Well what this means is that with an increase in budget and the fact that FDA are opening offices in Europe your companies will be seeing the inspectors on a far more frequent rate than before.

New FDA Commissioner Acts

In addition to the Act, there has also been a change at the top of the FDA with the appointment of Dr Margaret Hamburg as the new Commissioner in May 2009. On 6 August 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, able to enforce the law and being creative in promoting health. In this speech with an accompanying video,3 the following quotations were included:

  • 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 offences.