Compounded Drugs Should Be Regulated | Letter to the Editor

Posted November 1, 2013 at 12:14pm

In the Oct. 9 opinion piece “Drug Safety Bill Puts Urgent Treatment in Jeopardy,” Craig H. Kliger argues that the Drug Quality and Security Act (DQSA, H.R. 3204) would limit eye doctors’ access to drugs compounded in pharmacies. To the contrary, this legislation would improve the safety of these medicines.

A Pew analysis found that since 2005 at least 70 patients were hurt after receiving contaminated drugs compounded for ophthalmic use. One patient contracted infections of the brain and its surrounding tissue. Several suffered impaired vision; others went blind or had eyes surgically removed.

DQSA would address this problem by creating a new option for doctors and patients — a category of outsourcing facilities that would submit to higher quality standards and more rigorous Food and Drug Administration oversight in order to prepare drugs stocked in hospitals and clinics. Major public health advocates, patient groups and pharmacy associations support this legislation.

Doctors and patients would benefit from having a federally regulated source of compounded medications that are prepared under stronger quality standards than the drugs that harmed those 70 patients. The Senate should swiftly pass this bill.

— Allan Coukell, senior director of drugs and medical devices at The Pew Charitable Trusts