FDA & Compounders: More Oversight Needed?

By Ed Silverman

Over the past two years, compounded medications have figured in two highly controversial episodes. In one instance, Roche attempted to prevent ophthalmologists from using its older Avastin med for treating wet macular degeneration when its newer and more expensive Lucentis is the only approved treatment. The drugmaker has claimed that rejiggered vials of Avastin pose a safety risk (readhere and here).

In another, KV Pharmaceutical caused a huge ruckus by initially charging $1,500 for its Makena premature birth drug and trying to use its FDA approval under the Orphan Drug Act to prevent compounding pharmacies, which charged a fraction of the price, from competing. The move outraged physicians, among others, who maintained the compounded versions were safe and kept a lid on rising healthcare costs.

Now, an outbreak of meningitis that has been traced to a compounding pharmacy in Massachusetts has, once again, placed compounding in the spotlight, and renewed debate about the extent to which oversight is sufficient. The outbreak, which has left five people dead and another 30 in various stages of illness across six states, appears to have been caused by a compounded steroid drug contaminated by a fungus.

The drug has been recalled, but so far the pharmacy has shipped more than 17,000 to 75 clinics in 23 states, according to the FDA. More than 7,500 compounding pharmacies operate in the US, up from 5,000 in 2009, and account for $3 billion in sales and 3 percent of all prescriptions filled, the Associated Press writes, citing data from the International Academy of Compounding Pharmacies.

“There’s not a lot of oversight of compounding pharmacies” compared with drugmakers, Allen Vaida, executive vp of the Institute for Safe Medication Practices, tells the AP. And William Schaffner, an infectious-disease specialist at Vanderbilt University, adds that compounded meds “fall into this gray area and no one supervises in a rigorous fashion their manufacturing processes. The state pharmacy boards don’t have the resources or the knowledge or experience, and the FDA does not get involved unless a problem occurs.”

In the Makena flap, for instance, the FDA repeatedly stated that enforcement actions against compounded versions would not be pursued unless there was a safety risk, a stance that infuriated KV Pharmaceutical. The drugmaker, in fact, sued the agency for purportedly abdicating its responsibilities, but last month, a federal judge tossed the lawsuit, ruling that the FDA acted appropriately in exercising its discretion in whether to pursue enforcement actions against compounders (back story).

The FDA has, however, warned the New England Compounding Center, which has been blamed for the meningitis outbreak, in the past over its practices. In 2006, the agency sent a warning letter that, among other things, cited concerns about marketing anesthetic creams and potential microbial contamination associated with splitting and repackaging Avastin, here). And Massachusetts health officials have also investigated complaints over the past decade against the company, according to The Boston Globe.

This latest episode underscores the difficulties that both state pharmacy boards and the FDA have encountered in attempting to regulate compounders. Only 162 compounders have applied for voluntary industry accreditation of the 3,000 or so compounding pharmacies around the country, according to the International Academy of Compounding Pharmacies. The New England Compounding Center is not among them, The New York Times writes. Meanwhile, the company shipped across state lines, which further opened the door for the FDA to take action.

But the FDA’s authority to pursue compounders has been questioned. Last year, for instance, a federal judge ruled the agency overstepped its bounds in attempting to prevent compounders from using bulk ingredients to compound prescription meds for non-food producing animals. The case involved a compounder called Franck’s that made veterinary meds.

The issue, as we noted at the time, involved the basic premise that state-regulated compounding pharmacies should have the right to mix bulk ingredients in order to fill a prescription from a veterinarian. The FDA, however, worried such activity may offer the potential to blur the line between valid compounding and mass manufacturing of a new drug – and sought to exercise long-dormant authority over the practice (back story).

Of course, compounding serves an important purpose. Compounders provide meds for individual patients with special needs and prepare drugs that are not available commercially. The meningitis outbreak, however, may renew calls for stricter regulation, or at least to clarify the extent to which state pharmacy boards and the FDA should have clearly defined – and possibly enhanced – responsibilities to pursue enforcement. What do you think?

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