Regulatory Roundup

Published on: 
Pharmaceutical Technology, Pharmaceutical Technology-04-02-2013, Volume 37, Issue 4

Latest news about compound pharmacies, biosimilars, prescription drug purchases, and other regulatory topics.

FDA targets compounders

In response to complaints that FDA did not shut down the New England Compounding Center before its contaminated injectables killed and sickened hundreds of people, the agency has launched a broad inspection program of “high-risk” pharmacy compounders. The agency is visiting approximately 30 compounding pharmacies over several months, targeting facilities engaged in large-scale production of sterile products, particularly those with a history of violations and adverse event reports. FDA posted the results of its first four inspections last month, citing a range of lapses and faulty operations likely to lead to microbiological contamination. The agency has coordinated the inspections with state regulators, which will take enforcement action where FDA lacks authority. Similarly, surprise inspections of 37 specialty pharmacies by Massachusetts health authorities uncovered serious violations of state regulations and prompted the shutdown of 11 operations.

At the same time, manufacturers are pressing for legislation to strengthen FDA authority over compounders engaged in illegal drug production. Hospitals and veterinarians, however, are wary of new rules that could block access to specialized therapies. The prospects for compounding legislation recently gained momentum when the International Academy of Compounding Pharmacists signaled support for stronger FDA regulation of large-scale pharmacy operations.

Biosimilar battles

While FDA waits for the first biopharmaceutical manufacturer to file a biosimilar application, the fight is escalating over how these therapies will be tested, regulated, and dispensed. Abbott Laboratories is objecting to FDA approval of any biosimilar based on a reference drug approved before March 2010, when legislation was enacted authorizing these products. And just in case FDA ever decides that a biosimilar is interchangeable with the reference drug, innovator firms are backing bills in state legislatures to block pharmacy substitution of such products. This issue is pitting pharmacists against biotech manufacturers in Colorado, Mississippi, and other states. Meanwhile, Amgen unveiled an aggressive biosimilar development plan that focuses on leading cancer therapies, and Merck announced a new partnership with Samsung to develop biosimilars, after pulling back from earlier arrangements. FDA is meeting with potential biosimilar producers and working to finalize a development pathway, but the road to market remains rocky.

Spending drops for drugs, soars for biologics

US outlays in 2012 for conventional drugs dropped for the first time ever, according to Express Scripts, largely due to a steady rise in generic drug use. But this 1.5% decline, as reported in Express Scripts’ annual Drug Trend Report, was offset by an 18.4% jump in spending on specialty medications, led by treatments for rheumatoid arthritis, multiple sclerosis, cancer, and HIV. Two new products drove up outlays for hepatitis C treatments by 34%, while spending rose 23% for therapies for inflammatory conditions. Similarly, new cancer medications to treat unique genetic profiles boosted spending in this category. These figures on specialty drugs would be much higher if they included medications delivered in hospitals and clinics, where half of treatment takes place.

Meanwhile, ever-growing use of generic drugs, largely due to the “patent cliff” affecting several blockbuster medications, dropped unit costs for several key categories. The nation spent the most on diabetes treatments, and outlays rose 14% on therapies for attention disorders. The full report is available at Further insight on specialty drug management is available in an advisory on formulary submissions for these products from the Academy of Managed Care Pharmacy


CDER plans quality office

FDA’s Center for Drug Evaluation and Research (CDER) plans to establish a new Office of Pharmaceutical Quality to coordinate agency and industry efforts to avert drug shortages, tackle global supply issues, and ensure industry compliance with the rules. CDER Director Janet Woodcock has mentioned this change in recent months, and Commissioner Margaret Hamburg made it official in her February speech to the Generic Pharmaceutical Association. Hamburg said the goal is to “improve consistency and regulatory certainty across the wide span of drug quality review,” but not to change current GMP requirements. The tentative plan is to shift some parts of CDER’s Office of Compliance into this new home for the current Office of Pharmaceutical Science.

Drugs in the water

Researchers continue to find that even small traces of pharmaceuticals in rivers and streams can have harmful effects on fish, but it’s not clear what to do about it. The latest evidence comes from a study published in Science magazine by Swedish researchers who reported unusual harmful behaviors in perch exposed to very high concentrations of the anti-anxiety drug oxazepam (1). Other studies have revealed similar effects of antidepressants on minnows and of pharmaceutical ingredients on sexual characteristics of fish in France. Although there’s much talk about improving disposal of unused medicines, many authorities find drug ingredients enter waterways primarily through sewage systems. That has prompted calls for better water treatment methods, along with further research on drug impact on water life.


1. T.Brodin et al., Science, 339 (6121), pp. 814-815 (Feb. 15, 2013).