Representative Edward Markey calls for prosecution, if US drug laws were broken by Framingham pharmacy

WASHINGTON -- Representative Edward Markey on Tuesday called for the Justice Department to launch a criminal investigation -- and urged prosecution, if laws were broken -- against the Framingham pharmaceutical company that produced a tainted batch of steroid injections blamed for a deadly outbreak of fungal meningitis.

“If they broke the law, they should be punished,” Markey said in an interview on Tuesday. “Lives have been lost, many others have been harmed seriously. ...This compounding pharmacy was also compounding the risks.”

At least 15 people have died and 233 have been sickened because of contaminated batches of the steroid that was shipped to 76 facilities in 24 states by New England Compounding Center. Investigators believe that 14,000 people may have been injected with the drug.

“This is a deadly and serious situation involving highly sensitive drugs and vulnerable patients,” he said, adding that the situation “demands the strongest response from the [Drug Enforcement Agency] and the Congress.”

In a letter to the agency, the Malden Democrat asked federal investigators to determine if the company may have broken any laws dealing with controlled substances. He noted that the list of products being recalled by the company appears to include scores of formulations that, he said, contain such controlled substances as morphine and cocaine that fall under the jurisdiction of the Drug Enforcement Agency.

“This is a matter that I believe requires further investigation by the DEA to ensure that this facility, already believed to have broken Massachusetts state law, has not also skirted federal law related to controlled substances,” Markey wrote in his letter.

Since the outbreak was first reported, Markey, whose district includes Framingham, has escalated his calls for government intervention. Last week, he sought guidance from the Food and Drug Administration on what level of oversight should be imposed on so-called compounding pharmacies, which mostly operate outside the authority of federal regulators.

On Friday, Markey called for quick action from Congress -- which is unlikely because the body is on recess until after the Nov. 6 election -- to impose a comprehensive set of rules on such companies.

Compound pharmacies manufacture and distribute customized drugs for people who may not be able to use medication from traditional pharmacies. Critics say some compounding pharmacies are actually full-blown drug companies disguised under the law as sophisticated modern-day apothecaries to skirt the tougher regulations on larger pharmaceutical companies.

Markey wants compounding pharmacies to comply with minimum safety standards and issue warnings to patients informing them that compounded pharmaceuticals have not been approved as “safe and effective” by the FDA.

Federal regulations require pharmacies that manufacture or sell formulations that contain controlled substances to be registered with the DEA, Markey’s office said. And any such drugs must be sold directly to patients unless the firm is registered with the DEA as manufacturer or supplier.

According to Markey’s office, the DEA has informed him that the Framingham compounding pharmacy was not registered as such.

“We need to know if NECC violated federal law and is subject to enforcement action beyond any violations it may be subject to at the state level,” Markey said in a statement.

In his letter to the Justice Department, Markey sought clarification about what types of controlled substances New England Compounding Center was authorized to handle, and what actions can be taken against the company, among other questions.