What to Do About Drug Shortages

When it comes to addressing drug shortages, economic factors aren’t just “a contributing factor”; they’re the main factor.

Most of America’s drug shortages arise in the generics market, where profitability is fairly low. This market can sustain only a handful of manufacturers, so when supply disruptions occur, there aren’t a lot of additional producers (or in many cases any) in the market to pick up the slack.

Drugs that hold relatively stable prices, on the other hand, tend not to experience shortages, according to an October 2011 report by the Department of Health and Human Services. In other words, artificially low prices caused mainly by government programs — ranging from Medicaid to the problematic 340B discount drug program — have caused shortages. Where there’s still a profit, there are rarely shortages.

PETER J. PITTS
Washington, Feb. 11, 2014

The writer, a former associate commissioner of the Food and Drug Administration, is president of the Center for Medicine in the Public Interest.

To the Editor:

Drug shortages challenge patient care and pose a public health threat for infectious diseases like tuberculosis. The recent Government Accountability Office report showed that 16 percent of drug shortages were for anti-infective drugs.

In 2013, the two main products for diagnosing and treating TB were in shortage, endangering individual and public health. The Food and Drug Administration is not sufficiently empowered to address drug shortages. A proposed rule to expand the agency’s requirements for reporting shortages makes progress, but its vague language creates a loophole in mandatory reporting, and it gives the F.D.A. no enforcement authority.

Preventing drug shortages also requires encouraging reliable production from more suppliers. Perplexingly, while American dollars are funding global procurement of quality-assured TB medicines through the Global Drug Facility, American taxpayers cannot benefit from this stable drug supply.

The F.D.A. needs authorization to facilitate the entry of more global, quality-assured medicines into the United States. Finding innovative ways to reduce shortages for the diagnosis and treatment of drug-sensitive and -resistant TB is essential to eliminate the disease as a public health threat.

ERICA LESSEM
DONNA HOPE WEGENER
New York, Feb. 13, 2014

The writers are, respectively, assistant director of the TB/H.I.V. Project at the Treatment Action Group and executive director of the National TB Controllers Association.

To the Editor:

Oncology drug shortages force doctors to delay or cancel treatment. When this is not an option, alternative therapies, which may not be as effective or which carry an increased risk of adverse effects, must be used.

Shortages also pose a significant, negative effect on current and future cancer clinical trials: Delaying a clinical trial squanders the investment made by researchers, patients participating in the study and, not insignificantly, taxpayers.

While the recent Government Accountability Office report commends the Food and Drug Administration for reducing the total number of shortages, more must be done to understand the complex issues that contribute to the problem, and additional resources must be found so that the agency can carry out those policies and procedures that will allow greater oversight and control of the situation.

Nothing less than the health of millions of American cancer patients depends upon it.

ELIZABETH THOMPSON
Chief Executive
Lymphoma Research Foundation
New York, Feb. 12, 2014

http://www.nytimes.com/2014/02/18/opinion/what-to-do-about-drug-shortages.html?_r=0