Regulatory Roundup

New drug approvals

FDA hit a 15-year high with 39 new drug approvals in 2012, benefiting from a continued rise in commercial investigational new drug (IND) applications filed with FDA in the past two years. FDA approved more than 30 new molecular entities (NMEs) by early December 2012, reported John Jenkins, director of the Office of New Drugs (OND) in the Center for Drug Evaluation and Research (CDER), at Elsevier's FDA/CMS Summit in December 2012. Then the agency approved eight more applications before year-end, including treatments for a rare leukemia, chicken pox, and drug-resistant tuberculosis. FDA's performance continues to reduce drug lag with Europe, Jenkins noted, as more than 80% of NMEs approved in 2012 came to market first in the United States.

Legislation sought for compounders

Stung by charges that FDA failed to prevent the recent meningitis outbreak linked to contaminated products from a large Massachusetts drug compounding operation, FDA Commissioner Margaret Hamburg has pressed for Congress to clarify FDA's authority over large-volume compounders that ship products across state lines. Hamburg supports continued state oversight of traditional compounding pharmacies that produce custom treatments to fill specific patient prescriptions. But FDA wants large, "nontraditional" compounders to register with the agency, provide records for periodic inspections, meet certain production standards, and file adverse event reports on their products, as required for drug manufacturers. FDA agrees that compounders should not have to seek approval of new drug applications for every product they make, a process that would be costly and unnecessary for most compounded products, and that large-scale compounders are important for filling supply gaps, particularly in shortage situations, and provide hospitals with many needed products.

FDA met with officials from all 50 states in December 2012 to identify problems in overseeing compounders and to map out opportunities for better collaboration and communication. The state representatives stopped short of endorsing specific federal legislation, but acknowledged the need for clearer distinctions between compounding and manufacturing based on production volume, types of products, and interstate shipping. State officials said they are familiar with in-state pharmacies, but not with distant operators that ship in products. And many states complained of inadequate resources and limited authority to fully oversee compounders. FDA/state working groups will continue to explore these issues, while House and Senate committees weigh legislative proposals. A detailed history of pharmacy compounding is available from the International Pharmaceutical Quality newsletter, www.ipqpubs.com.

Paying for cleanup?

Drug and biotech companies are protesting a California county law that requires them to pay for a local drug "take-back" program, in hopes of heading off similar proposals from other states designed to prevent unintentional poisonings and improper disposal of pharmaceuticals into water systems. Alameda County enacted a law in July 2012 that makes pharmaceutical manufacturers responsible for "end-of-life management" of their products, based on California's "Extended Producer Responsibility" policy that imposes such requirements on items ranging from electronics and batteries to medical products. That requirement prompted a lawsuit from the Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Industry Organization (BIO), and the Generic Pharmaceutical Association (GPhA), claiming that the law infringes on interstate commerce by shifting local costs to national producers and consumers. California argues that drug companies can well afford the estimated $330,000 cost of running the collection program, but manufacturers counter that the price tag would add up to millions if every state adopted a similar policy—tantamount to requiring food producers to collect and dispose of spoiled food.