Friday, May 6, 2011

Drug Shortages: Blame Policies, Not Agencies

A recent article in the Washington Post by Rob Stein pointed out shortages of 211 medications in 2010, including lifesaving drugs used in emergency rooms and oncology wards ("Shortages of key drugs endanger patients"). What is causing this shortage? "Experts cite a confluence of factors," writes Stein:
Consolidation in the pharmaceutical industry has left only a few manufacturers for many older, less profitable products, meaning that when raw material runs short, equipment breaks down or government regulators crack down, the snags can quickly spiral into shortages.
Stein points out that there are especially acute shortages of generic medications (which aren't very profitable for manufacturers), especially sterile injectable medications (whose manufacturing processes are complicated and error-prone). There are also shortages of raw materials (often imported from abroad).

Stein cites the shortage of the leukemia and lymphoma drug cytarabine due to problems obtaining raw materials and manufacturing the drug. Cytarabine is a vital cancer drug that many hospitals have been forced to ration to patients. Inadequate medication substitutions have also lead to patient deaths, he said.

It's easy to blame the FDA for some of the problems with the drug supply. As Stein explains, "some industry representatives blame part of the problem on increased oversight by the FDA, which has made drug safety a higher priority after coming under intense criticism for being too lax." If the FDA would just skip a few manufacturing facility inspections, the supply pipeline would be smoother?

Drug supply problems don't originate with the FDA, however. Pharmaceutical manufacturers, eager to turn a healthy profit for their investors, would rather chase the next blockbuster drug (earning $1 billion or more in profits yearly) than thanklessly churn out low-profit items such as generic drugs and vaccines. Increasingly, venture capital firms that might fund new drug development would rather fund profitable new technologies than invest in better treatments for diseases.

The financial market, while it plays a role in drug development, should not drive public health decisions. The antidote to this problem is thoughtful legislation. Laws such as the Orphan Drug Act, which I've written about before, have successfully helped pharmaceutical companies refocus some of their energies on patient needs rather than profits.

Maybe the FDA could require that a company whose FDA-approved drug reached blockbuster status must ramp up its generic manufacturing to a certain level - building more manufacturing plants for a needed drug, or adding a popular vaccine to its roster -  before any more drugs are approved. Why not? Stronger regulations and incentives can encourage pharmaceutical manufacturers to diversify their assets and create a safer and more stable supply of drugs for everyone who might need them some day. 

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