The pharmaceutical industry is trying to head off a congressional push to loosen regulations for compounding pharmacies, a cheaper competitor.
Several pharmaceutical trade groups and public advocacy groups Pew Charitable Trusts and Trust for America’s Health wrote to Senate leaders Wednesday to keep regulations for compounding pharmacies intact. The impetus was a provision tucked into a House appropriations bill that would loosen compounding regulations.
Compounding involves a pharmacist making a personalized drug for a patient. For instance, if a drug is not available in a certain dose then a compounder can make it in that dose based on the patient’s prescription.
The House provision would allow a pharmacist to make a small amount of a drug in preparation for getting a prescription from a doctor, a practice called “office use” compounding.
The bill, which cleared the House Appropriations Committee last week, would ensure that the practice remains.
A report on the bill said that a 2013 law to bolster federal authority over the pharmacies improperly restricted the practice.
The appropriations bill calls on the Food and Drug Administration to issue guidance on how compounding pharmacies can properly do “office use.”
Senate appropriators are now starting work on their own FDA funding bill.
So drug companies want the Senate to leave out the “office use” provision in any version of their bill.
“Traditional pharmacies, primarily regulated by states, should not produce supplies of compounded drugs without prescriptions,” according to the letter obtained by the Washington Examiner. “The quality standards applied to pharmacies are appropriate for patient-specific preparations, but not for operations at a larger scale where significantly more individuals are exposed.”
Compounding pharmacies at times have offered cheaper versions of patented or generic drugs, making them an unlikely competitor for pharmaceutical companies. The 2013 law bans compounders from making essentially a copy of a drug already on the market.
However, some compounding pharmacies have sought to bypass such a provision.
For instance, when Turing Pharmaceuticals raised the price of the anti-malarial drug by 5,000 percent, a compounding pharmacy stepped in and offered the drug for $1. That was a steep discount from the $750 offered by Turing.
The compounding pharmacy industry, for its part, says the House is just enforcing the law as it was intended to be.
“For office use, the FDA continues to ignore clear Congressional intent … where the states have clearly indicated pathways in which pharmacies can participate in office use compounding,” said John Voliva, executive vice president of the trade group International Academy of Compounding Pharmacists.
The letter was sent to Sens. Thad Cochran, R-Miss., Barbara Mikulski, D-Md., Jerry Moran, R-Kan., and Jeff Merkley, D-Ore. Cochran is the chairman of the appropriations committee and Mikulski is the top Democrat, while Moran and Merkley run the subcommittee considering FDA funding.
The 2013 law stemmed from an outbreak of fungal meningitis linked to tainted drugs sent from a New England compounder. The outbreak killed more than 60 people and sickened more than 700.
It also sparked Congress to pass the Drug Quality and Security Act, which boosted federal oversight over compounders, which traditionally have been overseen by states.
