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A new policy debate over drug regulation is emerging as the NECC scandal worsens
As promised, US Rep. Edward Markey (D-MA) has introduced legislation, provisionally called the Verifying Authority and Legality in Drug (VALID) Compounding Act, in an attempt to clarify the distinction between pharmacies that compound drugs for individual patients (a very common practice) and those that perform compounding on a scale that makes them, in effect, drug manufacturers. The bill is a response to the widening scandal over contaminated, compounded steroid preparation that has (as of Oct. 31) led to the deaths of 28 and meningitis infection of 377 patients. New England Compounding Center (Framingham, MA; the company is in Markey’s Congressional district) produced around 17,000 dosages of the drug, methylprednisolone acetate, in early summer; the three lots of the compounded drug have now been recalled (along with other products of NECC) and the plant is shuttered.
Meanwhile, the Massachusetts state government has issued emergency rules to require compounding pharmacies to report volumes of drugs so produced, and to report to the state when other states are investigating a pharmacy’s products. It has also set up a commission to develop a report to the governor by year-end. “The compounding industry has evolved, and in some ways it has outgrown the current regulatory framework, not just the state but the federal regulatory framework,” said Governor Deval Patrick, according to a Boston Globe report.
The VALID Act specifies that compounded drugs be labeled as such (and with the notation that the drug has not been approved by FDA), and clarifies, to some degree, the distinction between pharmacies compounding drugs for individual patients (which has been and will continue to be under state regulatory authority) and those who are effectively engaged in manufacturing. The Secretary of HHS is to provide a list of drugs that are not to be compounded; and to prohibit the copying of commercially available drugs. A set of waivers allowing production of compounded product without individual prescriptions, and of certain types of pharmacies (such as those at hospitals) is also specified.
It’s not clear to what extent Markey’s proposed legislation would change the existing circumstances, except perhaps that physicians and patients are better informed that a compounded product is being dispensed. But even in that case, would a patient reconsider taking a drug that a physician is recommending? FDA already has authority to regulate what it believes to be manufacturers—but that authority has been under steady attack by trade associations affiliated with compounding pharmacists. Finally, FDA itself authorized the compounding (or, to be precise, announced that it did “not intend to take enforcement action against pharmacies” involved in the activity) of hydroxyprogesterone caproate, when KV Pharmaceuticals won approval to market that compound as a branded product, Makena, in 2011. KV (which is now in bankruptcy proceedings) intended to sell the drug for roughly $1,500 per injection, while the compounded product had been available for around $20.
Several trends are going to drive this debate: the heightened focus on using generic drugs as a cost-saving measure by health systems; the twists and turns that “personalized” medicine is taking—including bringing consumer interests and preferences into drug-dispensing decisions; and the intensifying push by pharmacists’ business and professional associations to have a greater say in prescribing practices. The ongoing drug-shortage problem has also played into this growing debate, as there are indications that a backup for some drugs in short supply has been to compound the product to address immediate needs (Markey’s bill specifies a waiver for “when necessary to protect public health”).