U.K. regulators shut down plant making potentially contaminated drug

Regulators in the U.K. have closed down a manufacturing operation there that was making unapproved, unlicensed globulin component macrophage activating factor, a blood product which has the potential to stimulate macrophages to kill cancer cells and stimulate the immune system but is not yet approved for use.

The Medicine and Healthcare products Regulatory Agency (MHRA) said the drug was being sold online throughout Europe as First Immune and peddled for treating cancer, HIV and autism. They said that they have not received any complaints of adverse reactions but warned that the drug might be contaminated and urged anyone who had bought it to see a doctor. They shut down the operation in Milton, Cambridgeshire, seizing 10,000 vials of the drug.

The MHRA said in a post on its website Tuesday that officials checked out the plant based on a complaint from the drug regulator in Guernsey. They found blood plasma starting material being used to make the drug that stated "Not to be administered to humans or used in any drug products." They also said the site was not following good manufacturing practices "and there are concerns over the sterility of the medicine being produced and the equipment being used."

Authorities said the products were sold through various European websites and they had alerted other countries to the risk.

Online sales of drugs have become a big headache for regulators, because counterfeit or unapproved drugs may be sold but the sites are hard to police and take action against. The international investigative agency Interpol has a unit fighting counterfeit drugs, including working to shut down websites that sell them.

Many jurisdictions, including the U.S., Europe and China, are moving to having specific identifiers on individual units of drugs that they hope can help deter counterfeiting, but it is taking time to get them implemented. The FDA said late last year it would not start enforcing most of the so-called track-and-trace rules that were to take effect January 1 until May, because so many smaller operations had been unable to implement them.

- read the MHRA post

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