FDA accuses drugmakers of blocking generics
FDA chief: Companies ‘gaming the system’
A day after President Trump lashed out at the CEO of drugmaker 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. Frazier resigned from the White House manufacturing council after Trump responded to the violent Charlottesville, Va., protests by blaming both sides in the racially charged clashes.
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 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, Gottlieb said. 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, said this tactic is a top reason one of his former medications became the most expensive drug Medicare covers. He said he welcomes the 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,” said Mitchell, who doesn’t accept funding from the pharmaceutical industry.
Mitchell said 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 said, while the median income of a Medicare beneficiary is about $24,000 per year.
The FDA received about 150 letters that generic companies sent to brand-name companies complaining about access to doses for their studies. About half involved the patient safety program, and the others involved specialty pharmacies and restrictive contracts that prevent distributors from selling to generic companies. Even if they aren’t illegal, Gottlieb said, there are ways the FDA can address the industry tactics because it’s good public health policy. One way is releasing the letters publicly, which the FDA plans to do.
“He’s trying to do what he can in shaming them and to push every level he can, but he will probably need congressional action to deal with it once and for all,” Mitchell said.
Bipartisan legislation is pending in Congress that would increase access to the samples.
Josh Sharfstein, a physician who was principal deputy FDA commissioner under President Obama, said addressing “market failures” like these is a “solid step the FDA can take.”
“This is an area where he has the opportunity to make pro- gress,” said Sharfstein, a professor at Johns Hopkins University’s Bloomberg School of Public Health.
Also discussed:
Tobacco. Late last month, the FDA announced a tobacco plan that includes reducing the nicotine in cigarettes and a delay in regulating electronic cigarettes. Though the delay marked a reversal of an Obama administration plan, Democrats and public health officials generally supported the more comprehensive approach to tobacco.
Jeff Stier, director of risk analysis at the free-market National Center for Public Policy Research, said he supports a “sequential approach” that ensures people who want to taper off lower-nicotine cigarettes can get ecigarettes if nicotine gum or patches don’t work.
Opioids. Gottlieb wants to focus on reducing the chance people get addicted. He wants to make sure patients aren’t “being prescribed opioids when other drugs might suffice.”
The FDA has stepped up inspections to catch illegal shipments of drugs such as the narcotic fentanyl, which has led to a surge in overdose deaths.