Masks, surgical gowns, testing of supplies on FDA deficiency list


Background: The deficit list was released hours after President Donald Trump demonstrated the progress his administration has made in securing critical protective gear and other supplies.

“We have increased the number of N95 masks by hand to more than 40 million, tripled the number of dresses to more than 15 million and doubled the number of fans to 69,000,” Trump said in a briefing on Friday, referring to the Strategic National Stockpile of the country.

But health care workers at smaller and poorer hospitals and medical systems say they are still struggling to get protective gear, personnel and resources to fight the coronavirus.

Trump has also repeatedly described the United States’ testing system as the best in the world.

Industry Response: Premier, a group purchasing organization, praised the FDA for publishing the list, saying the action is “a positive development that will provide more capabilities in the healthcare sector.”

“Over time, as this list evolves, we would like it to look more closely at the list of drug shortages, which is more accurate about the exact product and manufacturers in the market,” Blair said. Childs, premier senior vice president of public affairs. “This information is the key to enabling buyers to identify alternatives and customize the purchase.”

The device sector has historically been less concerned with such disclosure – earlier said the FDA should wait and see how the new provisions appointed by the CARES Act work before implementing additional reporting requirements.

Background: In May, the FDA introduced reporting requirements for device manufacturers. The agency expects the sector to warn the agency at least six months prior to stopping or interrupting critical devices.

What follows: The FDA has previously said it will work with Congress to expand requirements for disclosing shortages to device manufacturers.