Report: FDA to tighten pill manufacturing regs amid recalls

The Food and Drug Administration (FDA) plans to introduce stricter rules for drug manufacturers in light of a series of recalls of contaminated imports from China and India, according to Bloomberg.

“We’ve seen a lot of instances of adulterated products — contamination, impurities — recently,” outgoing FDA Commissioner Scott Gottlieb, who plans to leave his post in April, told Bloomberg.

“The underlying causes have been traced back to manufacturing, inadequate quality controls and generally poor management oversight,” he said.

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The agency currently largely relies on the drug industry to monitor itself with only occasional inspections of monitoring sites, but the increasing number of drugs and drug ingredients made for the American market in countries like India and China, where the FDA’s physical presence is limited, has put that approach to the test, according to Bloomberg.

The proposed rule changes will primarily affect active pharmaceutical ingredients, or APIs. Multiple companies have recalled drugs in recent months because of the presence of APIs potentially contaminated with carcinogenic materials. Valsartan, which can be taken alone or with other ingredients to treat heart failure or hypertension, is one of the most widely-used ingredients caught up in the recall, according to the article.

The contaminated APIs were bought by drugmakers who used them in products sold in the American market. India-based manufacturers Torrent Pharmaceuticals, Hetero Drugs and Aurobindo Pharma have all recently recalled cardiovascular drugs over the presence of probable carcinogens, according to the report.

These issues have drawn scrutiny from Congress as well. In February, the House Energy and Commerce Committee asked Gottlieb for further information about the agency’s manufacturing oversight after a Bloomberg investigation found inspections had dropped 11 percent between fiscal 2017 and fiscal 2018, according to the report.

The proposed reforms to manufacturing rules are still in early stages and may take several years to implement, Gottlieb noted.