As compounders have moved into bulk production, federal regulators have sent conflicting signals about when they will step in.
The drugmaker K-V Pharmaceutical, for instance, won FDA approval in February 2011 for its drug Makena, which is given to pregnant women to prevent premature births, and was given the exclusive right to sell it for seven years. But the following month, the FDA announced it would not take action against pharmacies compounding a similar product.
The day after that announcement, K-V’s stock dropped by more than 60 percent. Since then, the company has cut the per-dose price of Makena from $1,500 to $690.
That episode was widely noted across the drug industry, with compounding experts calling it a watershed moment.
Earlier this winter, officials from K-V Pharmaceuticals were on Capitol Hill for two days, lobbying on the issue and telling congressional staffers that compounded versions of Makena can be “unsafe or ineffective,” said Sarah Sellers, senior director of epidemiology and risk management for K-V’s marketing and distributing arm, Ther-RX.
“If an FDA-approved product is medically appropriate, it should be used preferentially,” Sellers said.
Manufacturers of animal drugs — such as Frontline for flea and tick prevention and Heartgard for heartworm prevention — have also been pushing Congress to stop compounders from making what drug companies consider copycat products.
Compounders say there are times they should be allowed to make products that are essentially copies — when manufactured products are unavailable because of drug shortages and when drugmakers have stopped producing a needed product.
Veterinary compounders and veterinarians are trying to block a push by drugmakers to require patient-specific prescriptions before a medication can be made. Matt Wilson, a partner at Animal Clinic Northview in Ohio, said this creates serious problems in emergency situations. For example, apomorphine is commonly used to induce vomiting in dogs when they have ingested a poison but it must be given within hours to save the pet.
“There are so many drugs that are back-ordered and unavailable. You can’t properly practice medicine if you don’t have these products in hand,” said Wilson, who uses Wedgewood Pharmacy, which is part of the lobbying effort.
Instead of measures that could limit mass production or bar compounds similar to commercial products, compounders are telling Congress they want more-rigorous safety standards for all compounding pharmacies.