Amid Coronavirus Outbreak, FDA Suspends Inspections Of Foreign Manufacturers Of Drugs, Medical Devices
FDA Commissioner Stephen Hahn said in a statement that the decision was based on State Department travel advisories and other restrictions that have been enforced during the outbreak.
The Washington Post:
FDA Suspends Overseas Drug Inspections Because Of Coronavirus
The Food and Drug Administration said Tuesday that it is postponing most inspections of foreign manufacturers of pharmaceutical products, medical devices and food imported into the United States. The inspections will be suspended through April. The agency said the postponements involve routine surveillance inspections of outfits that make FDA-regulated products. “For cause” inspections — ones in which the FDA is investigating a specific problem, for example — will be evaluated on a case-by-case basis. (McGinley, 3/10)
The New York Times:
F.D.A. Halts Overseas Inspections Of Drugs And Devices, Citing Coronavirus
The agency had already pulled back its inspectors from China, which is the largest source of raw ingredients for many drugs, like aspirin, ibuprofen and penicillin. But this global action means that F.D.A. inspections would also be discontinued in India, the world’s leading manufacturer of generic drugs. Last year, the agency said it conducted 3,103 inspections at overseas plants. In addition to overseas inspections, the agency also screens samples of food, drugs, tobacco, veterinary products and cosmetics imported into the United States. In recent years, several types of drugs have had to be recalled because of contamination at the production level, many of which contained ingredients made in China. Those recalls prompted the F.D.A. to revamp some of its procedures. (Kaplan and Thomas, 3/10)
In other pharmaceutical news —
The New York Times:
Coronavirus Spurs U.S. Efforts To End China’s Chokehold On Drugs
The global spread of the coronavirus is reigniting efforts by the Trump administration to encourage more American manufacturing of pharmaceuticals and reduce dependence on China for the drugs and medical products that fuel the federal health care system. The effort includes a push by the White House trade adviser Peter Navarro to tighten “Buy American” laws so federal agencies are required to purchase American-made pharmaceuticals and medical equipment, according to people with knowledge of the plans. (Swanson, 3/11)
Stat:
Global Companies Expand The Reach Of Their Cancer Drugs In China
While much of the world is understandably focused on the new coronavirus’s emergence in China, three recent developments involve the potential expansion of treatments for an entrenched disease there: cancer. One biotech is making it easier for patients to keep taking its checkpoint inhibitor, one pharma giant has won approval for a new type of cancer its targeted drug therapy can treat, and another major pharma has won the go-ahead for a combination therapy. (Chan, 3/10)
