House Passes Bill Regulating Specialty Pharmacies
Effectiveness of Legislation Still Questioned
The Wall Street Journal, THOMAS M. BURTON (Sept. 28, 2013)
The House on Saturday passed a bill regulating specialty pharmacies, seeking to prevent disease outbreaks like the one last year in which a pharmacy's tainted steroid injections caused 750 cases of spinal meningitis.But some in the industry and government questioned whether the bill, passed on a voice vote, would have that effect.
Many compounding pharmacies mix small batches of drugs under prescription for individual patients-—such as preparing medicine blended with chocolate milk for children. However, some have grown and act almost like drug manufacturers.
The push for legislation arose after the New England Compounding Center of Framingham, Mass., sold thousands of doses of the steroid methylprednisolone acetate tainted by fungus, the Food and Drug Administration found. The steroid shots led to spinal meningitis that sickened hundreds of people in 20 states and was linked to 64 deaths. NECC suspended operations in October 2012.
The FDA's ability to identify, inspect and regulate compounding pharmacies has grown murky over the years. The agency's authority over compounders was sometimes successfully challenged in court cases ruling that compounders were more appropriately regulated by state pharmacy boards.
The bill passed by the House allows compounding pharmacies voluntarily to place themselves under FDA regulation, giving the agency authority to perform inspections. But the legislation doesn't draw a clear line defining which, if any, compounders must be regulated by the FDA.
The Senate and House held extensive hearings earlier this year in which lawmakers struggled to find a way to distinguish small compounders filling prescriptions and multistate ones selling large batches to customers around the country, sometimes without prescriptions.
Allan Coukell, who oversees medical programs at the Pew Charitable Trusts, said the bill "is not as far-reaching as earlier versions, but it is a significant proposal." He and others who support the bill said compounders that sell to major hospitals may come to see FDA regulation as a kind of mark of quality, making it more difficult for pharmacies that skirt federal regulation to find customers.
Rep. Morgan Griffith (R., Va.), a member of the House Energy and Commerce Committee, which held hearings on the topic, called the bill "a first step at clarifying current law," but he agreed other steps likely will be necessary.
During House debate Saturday, Rep. Rosa DeLauro (D., Conn.) said "the voluntary approach…is not strong enough." She said that a company like NECC wouldn't have to register with the FDA under the legislation.
Some government officials familiar with the compounding industry expressed concern that the House bill, and a similar one before the Senate, would make it difficult for the FDA to become aware of all the specialty pharmacies selling large volumes and ensure that sterile products are produced under sanitary conditions.
Late Friday, the FDA issued a written statement saying the bill "takes a step forward." The agency said the bill "does not provide FDA with the additional authorities it sought, [but] it provides a regulatory framework for certain compounders who register with FDA."
Groups representing compounding pharmacists differed on their views about the bill.
The National Community Pharmacists Association, in a letter to House Republican and Democratic leaders, said the bill "provides a balanced and effective approach." But David G. Miller, executive vice president of the International Academy of Compounding Pharmacists, said the legislation doesn't go far enough in identifying the large-volume compounders and "will not further the safety of compounding medication, which was its only purpose."