Mar 28, 2019

FDA will tighten drug safety rules

FDA commissioner Scott Gottlieb. Photo: Drew Angerer/Getty Images

The Food and Drug Administration is planning to impose tougher safety requirements on the ingredients in prescription drugs, following an investigation by Bloomberg's Anna Edney into safety and quality issues at overseas facilities.

The bottom line: The active ingredients in many pharmaceuticals, especially generics, come from China and India, but the FDA has few inspectors on the ground in those countries. So it requires drugmakers to self-report safety or quality issues.

Details: The agency's new plan will require drugmakers to perform "more rigorous" safety and quality testing, Edney reports, with a focus on raw ingredients. It will also wants higher purity standards for the water that goes into drugs — contaminated water can contaminate the whole product.

  • "We've seen a lot of instances of adulterated products — contamination, impurities — recently," FDA commissioner Scott Gottlieb told Bloomberg. "The underlying causes have been traced back to manufacturing, inadequate quality controls and generally poor management oversight."

Go deeper: Get a refresher on Bloomberg repoter Anna Edney's investigation

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Timeline: The India-Pakistan conflict over Kashmir

Illustration: Aïda Amer/Axios

The deadly protests during President Trump's visit to India between Muslims and Hindus flared over a new citizenship law, which critics say is anti-Muslim, are the latest clash between adherents of the two religions.

The big picture: Predominantly Hindu India officially removed special privileges in August for its only Muslim-majority state, Jammu and Kashmir region, exacerbating tensions with Pakistan. The dispute over Jammu and Kashmir, which lies between India and Pakistan and is partially controlled by both countries, dates back seven decades. It has sparked three wars and sporadic threats of nuclear conflict. India is now attempting to change the status of Jammu and Kashmir, prompting Pakistan to warn of “impending genocide.”

TimelineArrow3 mins ago - World

Coronavirus spreads to new countries, while U.S. confirms 57 cases

Data: The Center for Systems Science and Engineering at Johns Hopkins, the CDC, and China's Health Ministry. Note: China numbers are for the mainland only and U.S. numbers include repatriated citizens.

Public health officials confirmed Tuesday the U.S. has 57 people with the novel coronavirus, mostly those repatriated from the Diamond Princess cruise ship — an increase they had expected after the passengers were allowed to return home from Japan against their initial advice.

The big picture: COVID-19 has killed more than 2,700 people and infected more than 80,000 others, mostly in mainland China. There's only been two cases of person-to-person infections in the U.S. so far, but the Centers for Disease Control and Prevention is now warning that Americans should prepare for a much broader outbreak here.

Go deeperArrowUpdated 1 hour ago - Health