FDA is nobody's "lapdog"

[Wes Bucey]

Just in case folks may still harbor the idea the FDA is a toothless tiger, even BIG drug companies can be humbled by the FDA:

Originally Posted by Reuters

FDA Seizes Glaxo's Paxil, Avandamet Drugs
Friday March 4, 11:22 AM EST
WASHINGTON (Reuters) - The U.S. Food and Drug Administration said on Friday that officials had seized batches of GlaxoSmithKline Plc's antidepressant Paxil CR and diabetes drug Avandamet because of concerns over manufacturing quality.
©2005 Reuters Limited.

The full press release by the FDA is here
http://www.fda.gov/bbs/topics/news/2005/NEW01162.html
Significant quote

Originally Posted by FDA

The agency is concerned that GSK's violation of manufacturing standards may have resulted in the production of poor quality drug products that could potentially pose risks to consumers. Among the violations noted during FDA's latest inspection was the finding that the Paxil CR tablets could split apart and patients could receive a portion of the tablets that lacks any active ingredient, or alternatively a portion that contains active ingredient and does not have the intended controlled-release effect. Additionally, FDA found that some Avandamet tablets did not have an accurate dose of rosiglitazone, an active ingredient in this product.
The seizures follow warrants issued by the U.S. District Courts for the District of Puerto Rico and the Eastern District of Tennessee. The seizures were executed today by the U.S. Marshals Service at GSK's Cidra, Puerto Rico manufacturing facility, its Knoxville, Tennessee distribution facility, and a Puerto Rico distribution facility. GSK has voluntarily recalled some of the affected lots of Paxil CR and Avandamet; however, it has failed to recall all affected lots of these products. This failure on the part of GSK resulted in today's seizures by federal authorities.

Jawboning and delay simply does NOT work with the FDA.

[Marc]

Beat me up for saying so, but one incident does not make the FDA a tiger.

[Wes Bucey]

Originally Posted by Marc

Beat me up for saying so, but one incident does not make the FDA a tiger.

For the past three years, they (FDA) have been getting tougher and tougher. My next-town neighbor, Abbott Laboratories, ended up paying a fortune (millions and millions of $$) to consultants and attorneys to extricate themselves from a shutdown over "lax" GMP.

The latest "dope slap" to the FDA over some drugs sailing through without adequate policing by FDA is going to stiffen FDA's resolve to look and act tough for the foreseeable future. FDA absolutely refuses to even listen to anecdotal evidence. Stonewalling by a regulated company is just plain "daring" the FDA to shut them down. When the FDA hits any one of the big companies, that just assures Congress will pay attention during the next budget session because no Congressman wants to be seen as handcuffing the FDA when it is "protecting" constituents.

Continued stonewalling by company officials really increases the odds of a "perp walk" in front of the press.

Are there really any smart pharmaceutical or medical device executives out there who feel the FDA is still a paper tiger? In today's regulatory climate, it is the TOP officials who go to jail, not the middle level staffers.

[Megani]

This year has been an eye opener for big pharma and rightfully so! They need to spend less time and money weighing the risks of getting caught and more on doing it right the first time! Paper tiger or not, the FDA has had their rump in a sling over their poor and inadequate inspection processes. It's time they stopped sending food inspectors to clinical trial sites. It's time big pharma spent more time and effort looking at the risks to subjects in regards to AE's and SAE's rather than what are the chances of getting caught if we let this slip by?! Look at the number of internal memos where they knew there were problems and refused to slow down to evaluate the issues! If necessary, give the FDA some dentures and better training for their inspectors and get them out in the field! Neither may like the idea, but it will save the time and money spent on all these recalls! I wonder which is more expensive in the long run??? What happened to ethics and patient safety?????

[Jim Wynne]

Originally Posted by Megani

What happened to ethics and patient safety?????

In one word, advertising. People go to their doctors these days demanding prescriptions for medications they've seen heavily advertised on TV, and they have no way of knowing anything about the efficacy or safety of the drugs in question. In the June '05 issue of Scientific American there's a letter from a physician that addresses the issue. In part it reads,

At present, the FDA has three options: to approve, deny or delay a new drug. Once a medication is approved, however, the FDA is powerless to prevent its advertisement to the public. I would propose a fourth option: provisional approval. If the company chooses to accept this status, then it may place the drug on the market and proceed to educate physicians but not advertise to the public. This plan would create a longer review period after release of the medication and keep the analysis more in the forum of scientific investigation.

A simple solution, I think, but its implementation is likely to be stymied by the chase for big bucks.

In defense of the FDA, we have to also remember that the US is well on its way to becoming a nation of scientific ignoramuses, so the population of potential well-trained inspectors is disturbingly small. Add to this the fact that the current administration in Washington is unprecedentedly anti-science, and it's no surprise that the FDA is perceived as a "paper tiger."

[Megani]

I agree with much of what you say, however, the FDA does little to improve its own policies and reputation! I recently looked into a program they had developed utilizing outside contract auditors for inspections. As an independent contract auditor, I really was interested. Having been a coordinator, CRA, and CQA, I was hopeful. Turns out that they have a program of sorts, you attend some courses, and then you have to ask 3 companies, I believe, to allow the FDA to come in and inspect their facilities with you as a training session. Also, they are only usuing large Registrar companies, which have their own form of bureaucracy. I spoke with one of the companies and they said that they were not very successful at getting the program going, as no company wanted to invite the FDA to come in voluntarily. What good is a program like that? Sure, they can now tell HHS and Congress that they have implemented a program to bring in more inspectors, but they have made it basically impossible for the program to succeed. In the meantime, they send out food inspectors to inspect clinical vendors, give them no 483s, when the HHS and sponsor auditors go to the same site and write them up for multiple infractions. Then what do we hear from the vendor? "The FDA didn't think it was wrong, so we are not changing our policies." Thanks FDA, DUH!!

[Wes Bucey]

Obviously, FDA has a long way to go to reach perfection, according to Megani. That doesn't belie the original post in this thread that the FDA is cracking down much harder when it finds nonconformances. The question is rightly raised whether the FDA inspection system is as good and as thorough as it should be. I think most informed observers would say there is still a lot of bureaucratic folderol getting in the way of efficiency.