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FDA To Regulate Larger Drug Compounding Companies

Compounding Companies Face New Oversight

Followers of this False Claims Act blog know that we’ve written about drug compounding companies several times in the past. The meningitis outbreak caused by lax procedures at New England Compounding Center (NECC) served as a wake-up call to regulators and to Congress, leading to new legislation clarifying the boundaries between federal and state oversight of these companies.

These new laws, specifically the Compounding Quality Act (i.e., Title I of the Drug Quality and Security Act), made clear that small retail pharmacies that fill individual prescriptions of compounded drugs will remain primarily under state regulation. But, for those compounding companies registering as “outsourcing facilities,” the Food and Drug Administration (FDA) will assume jurisdiction, including the right to inspect the facilities. The term “outsourcing facilities” is carefully defined in the statute. The FDA’s website has clear guidance on when and how a facility should consider voluntarily registering.

Compounding Companies Oppose Reforms

Despite these too-bright-to-miss lines, some folks are determined to tell us that the new rules are confusing and we really should go back to the good old days of unregulated inter-state actors making people seriously sick. Who would those folks be? Why the International Academy of Compounding Pharmacists (IACP), of course.

The “Academy” is not an academy at all, but rather a “professional association” (ahem, lobbying organization) that purports to speak for the entire industry, ranging from the Mom and Pop pharmacists to the big drug re-packagers operating nationally with no direct relationship to patients. Here’s what their website says:

The International Academy of Compounding Pharmacists (“IACP”) is a professional association founded in 1991 to protect, promote and advance personalized medication solutions. The association represents more than 2,100 pharmacists and pharmacist technicians located throughout North America, South America, Europe, Australia and Asia, who are committed to the safe and ethical practice of pharmacy compounding. In addition, IACP represents more than 159,527 patients, physicians, veterinarians and nurse practitioners through its ally grassroots organization, Patients & Professionals for Customized Care. IACP is committed to ensuring the rights of practitioners to prescribe, of pharmacists to prepare, and of patients to take personalized medication solutions that meet their unique, individual health needs.

We’re curious to know, in the aftermath of the NECC’s patient deaths, what patients would sign up to be members of an organization that has actively opposed the efforts of the FDA to implement Congress’s mandate for safer drug laws? Are there really patients out there who think that we are better off having state pharmacy licensing boards try to regulate inter-state actors who mix drug products, even though the states themselves testified before Congress that they were powerless to regulate activities outside their borders? We can understand why compounding pharmacies might oppose a change from the status quo (industry always resists if the status quo is working for it), but individual patients? No one is proposing that patients be denied medications; Congress is merely trying to make sure that those medications are safe.

Compounding Industry Lobbying Efforts

One could be forgiven for being a little skeptical here about the IACP’s claim to be a “grassroots” patient-centric organization.

What the IACP really has been all about recently is (1) trying to oppose the effort in Congress to clarify the FDA’s jurisdiction over these manufacturing-scale activities (that didn’t work so well), and (2) trying to confuse people about what the FDA is doing to implement its rules under the new legislation (we’ll see how this one goes). All this despite the clear Congressional intent to clean up an industry that had operated without sufficient oversight for too long.

A recent exchange of correspondence between the IACP and the FDA is revealing. It started out harmlessly enough with the FDA writing to states to inform them of the new laws and how the FDA would be implementing them.  An almost identical letter went out to hospitals, state boards of health, and state boards of pharmacies. The letter outlined the history and context for the legislation and described the voluntary system in which drug compounding companies could register with the FDA as outsourcing facilities, effectively classifying themselves as something larger than a traditional pharmacy. These “outsourcing facilities” will not be subject to the agency’s full labeling requirements but will be subject to the agency’s rules governing safe manufacturing practices, also known as “current good manufacturing practices” or “cGMPs.” They would also be signing up for the right to be inspected by the FDA for safety purposes. (If you are an “outsourcing facility” that does not voluntarily register with the FDA, then you are subject to the additional labeling and new drug rules governing drug manufacturers; thus, there is an incentive to register.) In effect, what this new system does is make an important distinction between small retail pharmacies and large inter-state actors who are engaging in far more than pharmacy practice–the very source of the problem with the previously inadequately regulated NECCs of the world.

The IACP, however, cried foul, claiming that the agency’s attempt to drum up support for voluntary registration of outsourcing facilities was both unclear and premature. The letter went on to claim that by listing certain compounding pharmacies as outsourcing facilities on the agency’s website, the FEDA might be inadvertently confusing the public into thinking that all such listed facilities had been inspected and approved.

FDA Pushes Back Against Industry Objections

The Agency made quick work of these assertions in its response. The FDA publishes weekly updates about the status of outsourcing facilities, and patients and hospitals can have greater confidence that they are buying drugs from an entity that at least complies with good production and safety practices. And this is a voluntary system, anyway: “Because compounders are not required to register as outsourcing facilities, it is hoped that market forces will create demand for products made at outsourcing facilities, which operate under CGMP requirements, are subject to risk based inspection schedule by FDA, and meet certain other conditions such as reporting adverse events and labeling their products with information important to purchasers.” In other words, consumers might actually prefer to know that their drugs are being made in a way that is closely monitored and complies with basic safety requirements–and that the facility has nothing to hide from the public by remaining unregistered. Would you rather buy your drugs from an FDA-registered facility or one that elected not to?

Some compounding companies have voluntarily shut up shop rather than accept FDA’s jurisdiction over its operations.  Now there’s something to chew on: a company that was making a lot of money in the shadows now says we’d rather not operate in full daylight, with people actually watching what we do. Makes you wonder, doesn’t it?

But at least some people are recognizing that the landscape has changed. As for the IACP, it is still in denial, wishing we could just go back to the good old days–the good old days which we now know involved “contaminated products, and poor sterile practices,” according to the results of the FDA’s inspections of 70 different compounding pharmacies across the country. Maybe they were the good days for the compounders’ profits, but not so good for patients.

It’s time to smell the coffee. The new compounding law is here and here to stay.

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