Lawmakers seek more regulation of compounded drugs

WASHINGTON (AP) -- Two Democratic lawmakers on Tuesday called for stricter federal oversight of compounding pharmacies in the wake a deadly meningitis outbreak linked to contaminated injections made by a Massachusetts specialty pharmacy.

Representatives Rosa DeLauro and Edward Markey said in separate statements that they will draft legislation to give the Food and Drug Administration more authority to police the safety of custom-mixed medicines, known as compounded drugs.

Compounding pharmacies traditionally supply products that are not available commercially, based on an individual doctor's prescription. But some pharmacies have grown into larger businesses, operating across state lines and supplying drugs to thousands of hospitals, clinics and physicians.

As many as 13,000 people received steroid shots from the New England Compounding Center of Framingham, Mass, according to The Centers for Disease Control and Prevention.

The contaminated shots have now been associated with 119 cases of meningitis, including 11 deaths, the agency said Tuesday. The company has recalled the fungus-contaminated steroid, which was shipped to 23 states.

Meningitis is an inflammation of the lining of the brain and spinal cord. Symptoms include severe headache, nausea, dizziness and fever.

Unlike drugs manufactured by large pharmaceutical companies, compounded drugs have never been reviewed for safety and effectiveness by FDA. Compounding pharmacies have long operated in a legal gray area between state and federal laws. Efforts to more tightly regulate the industry have been knocked down by federal courts, including the Supreme Court.

Despite that history, Markey said Tuesday the FDA should have authority to bar compounding pharmacies from using ingredients that haven't been cleared by the agency. The Massachusetts congressman says his legislation would also require the pharmacies to report all safety issues to the FDA.

"Unfortunately, compounding pharmacies are a 19th century service operating in a 21st century industry, and we need to update and strengthen the rules that govern these operations so that patients can safely benefit from the unique service they offer," said Markey, who sits on the House Energy and Commerce Committee, which oversees the FDA.

Rep. DeLauro of Connecticut sent a letter Tuesday to Department of Health and Human Services Secretary Kathleen Sebelius, asking what additional powers would help the department improve the safety of compounded drugs.

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Lawmakers seek more regulation of compounded drugs