August 15, 2017 News

USA Today: FDA Chief Says Drug Makers are Gaming the System to Slow Generic Competition; Vows Action

August 15

Jayne O’Donnell

A day after President Trump lashed out at the black CEO of drug maker Merck on Twitter, his new Food and Drug Administration commissioner said brand name drug companies are “gaming the system” to block generic competition and vowed to do something about it.

Physician and FDA chief Scott Gottlieb declined to comment on Trump’s tweet urging Merck’s Kenneth Frazier to lower drug prices after Trump’s response to the violent Charlottesville, Va., protests prompted Frazier to resign from the White House manufacturing council. However, in a meeting Tuesday with USA TODAY’s Editorial Board, Gottlieb didn’t mince words when it came to his plans to stop what he said are anti-competitive actions by brand-name pharmaceutical companies that keep prices high.

He also touted the FDA’s record 100 generic drug approvals last month and said he hopes to cut the review time for generic drugs from four years to about 10 months.

Drugmakers “game the system and game the rules” through a patient safety program that allows them to keep generic drug companies from getting enough doses of their branded drug, said Gottlieb. Generic drugmakers need up to 5,000 doses to do the studies needed to prove their products are truly equivalent, he said.

David Mitchell, a multiple myeloma patient who founded the group Patients for Affordable Drugs, says this tactic is a top reason one of his former medications became the most expensive drug Medicare covers. He said he welcomes FDA’s focus on it.

“It’s not in and of itself going to solve the problem of high drug prices, but stopping those abuses would help a lot of patients,” says Mitchell, who doesn’t accept funding from any entity in the pharmaceutical industry.

Mitchell says his out-of-pocket cost for Revlimid went from $42 a month in 2011 to $250 a month by the time he had to stop taking it last year because of side effects. The median out-of-pocket cost for a Medicare beneficiary taking Revlimid is $11,500 per year, he notes, while the median income of a Medicare beneficiary is about $24,000 per year.


Patients For Affordable Drugs is the only independent national patient organization focused exclusively on achieving policy changes to lower the price of prescription drugs.