Drugmakers, hospitals, health care groups seek end to government shutdown

It’s not just the TSA, DHS, federal and contract workers and civilians dependent on the services provided by these organizations who are looking for a speedy end to the government shutdown. Now hospitals, health care groups and drugmakers are all piling on.

Modern Healthcare reports that “hundreds of groups,” from hospitals to major health care industry organizations, have sent letters to the White House and to the president pushing for an end to the government shutdown, lest it affect the health of U.S. citizens.

Among the many agencies shuttered by lack of funds are the U.S. Food and Drug Administration, the Indian Health Service (IHS) and the EPA, as well as other major agencies. The shutdown is already the longest on record, and health groups warn of possible long-term consequences to health and well-being if it is not terminated.

In their letter, the groups wrote, “We fear a prolonged shutdown will cause needless suffering and have long-lasting health consequences. Basic health protections could be endangered by an ongoing shutdown.”

Food inspections aren’t being done, except for certain high-risk foods—by inspectors called back from furloughs but still not being paid. The groups pointed out that 80 percent of the country’s food supply is overseen by the FDA, which carries out those inspections to try to ward off foodborne illnesses.

The letter, according to Modern Healthcare, also sounds the alarm about lapses in programs funded through the U.S. Department of Agriculture, such as the Supplemental Nutrition Assistance Program and the nutritional program for Women, Infants and Children. It also cautions the White House about the plight of and potential health consequences for the 800,000 furloughed and working-without-pay federal workers, writing, “Residents simply cannot maintain their health without stable housing, food and medical care.”

And they’re not the only ones rooting for restoration of the FDA; drugmakers who are stymied by the shutdown in trying to get new generic drugs approved are also in limbo, along with the hospitals waiting for those drugs. In another report, Modern Healthcare said that although generic-drug applications submitted before the partial government shutdown are still being approved—they’re financed by fees paid by drugmakers—no new applications are being accepted at present because the agency can’t collect any user fees.

“An unintended consequence of the government shutdown is the FDA will not be able to bring generic drugs to market as quickly as it otherwise might,” Peter Pitts, a former FDA official and the president of the Center for Medicine in the Public Interest, is quoted saying. Pitts added, “Nobody thinks that is a good idea, except perhaps brand-name drugs that get an unexpected windfall of extra (market) exclusivity.”

Expensive biologic drugs are keeping prices high, with more affordable biosimilars stalled awaiting FDA approvals. There too the inability to collect new fees for new applications is holding up the process that could help lower drug prices—something that the FDA had made a priority, along with approving new generics and increasing competition in an effort to lower generic prices.

Even when the shutdown ends, there is likely to be a flood of new applications for drug approvals—and that backlog won’t be cleared overnight.


Posted 11:00 AM

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