A Bill Gives FDA More Power Over Compounders

In the wake of the ongoing scandal over a meningitis outbreak traced to a compounder, a Massachusetts congressman has introduced legislation that is designed to close alleged legal loopholes that prevented the FDA from taking swifter action. The Verifying Authority and Legality in Drug (VALID) Compounding Act would give the agency authority to oversee compounding pharmacies throughout the country, according to Congressman Ed Markey.

“Compounding pharmacies have been governed by fragmented regulations for too long, leading to the worst public health disaster in recent memory,” Markey says in a statement. “The VALID Compounding Act ends this regulatory black hole by giving the FDA new, clear authority to protect patients and oversee these companies."

The crisis emerged earlier this month and the New England Compounding Center, which is based in Framingham, Massachusetts, has been pointed to as the source of contaminated injectable steroids that have led to 28 deaths and 377 illnesses in 19 states. The NECC was closed and an FDA inspection found numerous places where bacteria and mold were lurking in supposed 'clean rooms' used to store materials and prepare treatments (back story with FDA report and the latest from the FDA).

The legislation (which you can read here) is designed to address confusion over the role of the FDA, as well as state authorities, in regulating compounding pharmacies. The agency and others say court rulings have restricted its ability to respond unless a clear safety issue has been identified or a compounder engages in the equivalent of mass production and distribution that is more akin to the activities of a regular drugmaker. The NECC, for instance, engaged in such activity.

For this reaosn, others maintain the FDA already possessed the legal authority to pursue an enforcement action against NECC, which received an agency warning letter back in 2006 for various violations that raised concerns about its manufacturing and quality control procedures. Nonetheless, Markey does not want to take any chances and hopes that his legislation will strike the proverbial bi-partisan chord and become law.

Earlier this week, he also released a report purportedly showing that, since June 2001, the FDA attempted to "rein in the activities of dozens of pharmacies through the issuance of warning letters, all of which are publicly available... And that FDA records document 23 deaths and at least 86 serious illnesses or injuries associated with these practices" (here is the report).

9 Comments

Nov 2, 2012 - 1:27pm
I think the horse is already long gone. This barn door is a little late.
Nov 2, 2012 - 2:02pm
Not sure how this helps.
Nov 2, 2012 - 2:37pm
Pure politics, I guess the Congressman just wants to leave his mark(ey)...

... I'm here all week.... :-)

Nov 2, 2012 - 3:01pm
I don't know whether passage of this legislation would help the situation or not, but I do know that Congressman Markey has long been a chamption of stricter prescription drug safety at the F.D.A...he worked hard to get tougher language for this in the 2007 PDUFA reauthorization but acknowledged that the pharma lobby took care of out - making sure that all the tougher language was stripped out of the bill at the eleventh hour.

Congressman Markey is not a "pure politics" type of guy, and my hat is off to him.

Nov 2, 2012 - 3:21pm
My thought is that it would take 7.75 years of an eight year appointment for the Secretary to understand and be properly implement this.

Also, while the congressman's report cites state pharmacy boards, other state health agencies may also have oversight capacity over compounding pharmacies.

Nov 2, 2012 - 3:40pm
Alternatively, each state prosecutor with a victim should charge each NECC executive and "clean room" employee with negligent homicide. Personal consequence of facing jail time may make compounders more concerned re: public health.
Nov 2, 2012 - 4:06pm
FYI - much of the language offerred by Rep. Markey was taken from the section on Pharmacy Compounding in the Food and Drug Modernization Act, 1997. The provisions of that legislation, with the exception of the advertising restrictions which led to the downfall of the whole package, were reasonably conceived and likley would have been effective in preventing the unregulated growth of NECC et al. had the FDA chosen to implement and enforce the non-unconstitutional sections. Rather they argued for the non-severability of the advertising section and were happy to never have to deal with the issue again!??!
Nov 2, 2012 - 5:27pm
Thank you for that bit of news HawkiRX...looks as if Rep. Markey was on the mark, so to speak.
Nov 5, 2012 - 7:57am
According to the FDA's webpage on Facts About cGMP-Current Good Manufacturing Practice:

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm169105.htm

"Why are cGMPs so important?

A consumer usually cannot detect (through smell, touch, or sight) that a drug product is safe or if it will work."

However: "How does FDA determine if a company is complying with cGMP regulations?

FDA inspects pharmaceutical manufacturing facilities worldwide using scientifically and cGMP- trained individuals whose job it is to evaluate whether the company is following the cGMP regulations. FDA also relies upon reports of potentially defective drug products from the public and the industry. FDA will often use these reports to identify sites for which an inspection or investigation is needed. "

But...:

"If a manufacturer is not following cGMPs, are drug products safe for use?

If a company is not complying with cGMP regulations, any drug it makes is considered “adulterated” under the law. This kind of adulteration means that the drug was not manufactured under conditions that comply with cGMP. It does not mean that there is necessarily something wrong with the drug.

For consumers currently taking medicines from a company that was not following cGMPs, FDA usually advises these consumers not to interrupt their drug therapy, which could have serious implications for their health."

So, here is what the FDA advises:

"Consumers should seek advice from their health care professionals before stopping or changing medications."

So, unless I am misinterpreting this, the consumer and health care professional - who may be held liable under the learned intermediary doctrine- are relying on the FDA and other regulatory agencies such as the Justice Department and state agencies to identify and protect them from adulterated drugs. They also likely assume that FDA and other agencies will be proactive.

However, according to their website, the FDA relies on reports from consumers, health care professionals and industry. In addition, the FDA's current policy is usually to advise consumers to continue taking drugs that they have deemed adulterated in a FDA Warning Letter or after an Import Alert and ban.

Is it me, or is this confusing?