4,000 generic drugs awaiting FDA approval

generic drugs

The U.S. Food and Drug Administration has recently started working to clear a backlog of 4,000 generic drugs awaiting approval and is looking at other ways to increase competition, one of several steps being taken to increase competition in hopes of reducing drug prices.

“No patient should be priced out of the medicines they need, and as an agency dedicated to promoting public health, we must do our part to help patients get access to the treatments they require,” said FDA Commissioner Scott Gottlieb, M.D., in June.  “Getting safe and effective generic products to market in an efficient way, being risk-based in our own work and making sure our rules aren’t used to create obstacles to new competition can all help make sure that patients have access to more lower-cost options.”

Former Rep. Henry Waxman (D-Calif.) praised Gottlieb’s efforts at a recent conference. “In the past, the FDA said they were not going to look at those issues, but the new commissioner recognizes there is a role for FDA in dealing with high prices,” Waxman said.

“We know the American public is outraged at the high price of drugs,” Waxman said. “We know that people are being overcharged so they can’t even afford them.” Some patients try to deal with high drug costs by cutting medication into smaller doses and some simply stop taking their drugs, putting themselves at risk of complications and death.

Gottlieb has said the FDA is changing its policy for reviewing generic drug applications and will expedite reviews until there are three approved generics for a given drug product. That policy shift is based on data that indicate consumers see significant price reductions when there are multiple FDA-approved generics available.

“I am committed to continuing to pursue additional policy steps, under the FDA’s current authority, to help reduce the burden on patients who have a difficult time paying for the medicines they need,” Gottlieb said in his June statement.

Generic drugs can save billions

Waxman spoke at an August 2 conference sponsored by the Alliance for Health Policy. Other speakers included Steve Miller, M.D., M.B.A., senior vice president and chief medical officer of Express Scripts. He also pointed to competition as one solution to the problem of high prices.

Miller said his company conducted a study that found transitioning 11 selected drugs to biosimilars that cost 30 percent less would save $250 billion, and Miller said that despite widespread belief to the contrary, lower prices can exist alongside innovation. “You can have both,” he said.

Prescription drug costs take 10 cents out of every dollar spent on U.S. health care, and the United States accounts for 33 percent of world spending on prescription drugs despite accounting for only 4 percent of the world’s population.

“Prescription drugs are the most frequently accessed part of the health care system,” said Joel White, president of the Council for Affordable Health Coverage. “You go to the pharmacy once a month; you don’t go to the hospital once a month.”


About the Author

Truman Lewis
Truman has been a bureau chief and correspondent in D.C., Los Angeles, Phoenix and elsewhere, reporting for radio, television, print and news services, for more than 30 years. Most recently, he has reported extensively on health and consumer issues for ConsumerAffairs.com and FairfaxNews.com.