Speed-up Generic Drug Approval? It’s Already Done; But is it a Good Thing?

by Terry Bryant

The Food and Drug Administration (FDA) approved 1,027 generic drugs last year, a record number, the Trump administration said shortly after the New Year. The disclosure came as part of Trump’s efforts to fight high drug prices.

Generic drugs comprised nearly 9 of every 10 approved prescription drugs in the U.S. last year, according to the Department of Health and Human Services (HHS), due to relaxed policies that facilitate their development and an acceleration of regulatory approval beginning in 2014.

Despite this success, generic-drug makers face multiple legal and competitive hurdles to providing less costly, high-quality medicines. Tight profit margins on conventional generics hobble investment in modern manufacturing processes. Often this results in contaminated products that result in recalls and shortages. Price hikes on established products have generated some backlash, accompanied by allegations of collusion and price gouging instead of an overall lowering of prices.

Generic Drug Approval Process

The Trump administration – claiming to deliver on a campaign promise – released new guidelines in early January 2018 with the purpose of shrinking the approval process even further than 2014’s average of four years. “The goal is,” according to FDA Commissioner Dr. Scott Gottlieb, “to cut down on what are called multiple [generic drug application] cycles of review.”

“We’re going to streamline the FDA,” Trump said in passing, as he signed a blanket executive order mandating that all federal agencies cut two regulations for every new one. But relative to the generic drug approval rate, some wonder if the President is taking credit for the hard work of others.

Former FDA Commissioner Dr. David Kessler headed the Agency in the 1990s. And he says the generic drug approval process has already met Trump’s 10-month mandate.

“Every administration for the last 40 years has talked about speeding up drug approval,” Kessler told NBC News. “The reality is that we’re the fastest in the world. If you get sick and live in the United States, chances are you are going to have access to a drug first. It’s going to be approved first in the United States.”

But the approval times notwithstanding, the FDA should also be about doing good work. And in that regard, maybe for the sake of speed, is the overall drug approval process lacking in other ways?

In 2008, two out of every five new drug applications were approved. But the odds improved to three-in-five by 2012, according to PriceWaterhouseCoopers, due to the FDA’s more “intimate” relationship with drug makers.

Such intimacy has some consumer protection and FDA watchdog groups pointing to such accelerated approval failures as the controversial muscular dystrophy drug eteplirsen over the objections of the FDA’s own advisers. Almost two years later, it is unclear whether the Agency’s approval will remain based on the data used during its approval cycle or whether they’ll have to start all over again with better data. And though this occurred during the Obama administration, Dr. Michael Carome, director of Public Citizen’s Health Research Group, laments the current lack of stringent oversight and Big Pharma’s exerting too much “muscle” against the FDA; he points to eteplirsen’s approval process as proof that all is not well.

“The end result would be countless preventable deaths, injuries, and illnesses across the U.S.,” says Carome. He concludes, “Trump’s horrifying proposal reflects utter ignorance about the FDA’s essential role in protecting public health.”

If you have any questions about prescription drugs and the FDA approval process, you are encouraged to contact the Terry Bryant Accident & Injury Law Firm at toll-free 1 (800) 444-5000 or send us an online message.