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President Donald Trump said he wants to lower prescription drug prices in his Jan. 30 State of the Union address, but critics responded that they’ve heard similar comments before that didn’t translate into actions.
Trump said fixing high drug prices will be one of his top priorities and “prices will come down substantially, watch.” But exactly a year ago, on Jan. 31, 2017, he told drugmakers at a White house meeting they were charging too much and wanted to lower prices. Advocates of lower drug prices said they’re still waiting for something to happen.
Rep. Elijah Cummings (D-Md.) said in a statement after the president’s Jan. 30 speech he has tried “over and over” to work with Trump, including meeting with him and providing him with a draft bill that would allow federal officials to negotiate drug prices for Medicare beneficiaries. “All I have heard back is radio silence,” Cummings said.
“I await his actions on this crucial necessity as I did when he made this promise last year,” Cummings said.
However, an industry group and a health-care lawyer noted that the Trump administration has taken steps to increase approvals of lower-cost generic versions of drugs in the past year.
And in a statement provided to Bloomberg Law after the president’s speech, the Pharmaceutical Research and Manufacturers of America--representing brand-name companies--defended the pharma industry and pointed to other parts of the health-care industry as deserving scrutiny. “As we consider reforms, it is important to focus on costs across our complex health care system, including those being retained by the biopharmaceutical supply chain and the impact of hospital mark ups on medicine prices,” PhRMA said.
The critics included a public interest group representative, who said Trump “is all talk and no action” on drug prices. Michael Carome, director of Public Citizen’s Health Research Group, told Bloomberg Law Jan. 31 that the president has “taken actions that suggest he really has no interest in seeing drug prices lowered and is more interested in benefiting industry and their lobbyists.”
“He opened the revolving door between the pharmaceutical industry and government by appointing a secretary of health and human services, Alex Azar, and a commissioner of the FDA [Scott Gottlieb] who came directly from industry,” Carome said. “And Azar came from a company that routinely escalated prices and there’s no reason to believe that he’s someone who’s going to take substantial actions to lower drug prices.”
Azar was an executive at the drug company Eli Lilly & Co.
Thomas Huelskoetter, a health policy analyst at the Center for American Progress, also said Trump talked a lot about this issue during his campaign and he’s been in office a year and hasn’t really done anything on it. “There wasn’t a specific proposal in the speech” on drug prices, Huelskoetter said. As there was no specific proposal, “I didn’t take it as a meaningful shift on efforts to bring down prices.”
During his address, Trump also pointed out that the Food and Drug Administration approved a record number of generic drugs in 2017.
During 2017, the FDA said it approved 763 generic drug applications, compared to 651 in 2016 and 492 in 2015.
“Like many things he’s claiming credit for, it’s likely his being in office had no impact on the generic approvals that occurred during the last year,” Carome said.
While there was a record number of approvals in 2017, there also was a record number of approvals in 2015 and 2016, Allan Coukell, Pew Charitable Trusts’ senior director for health programs. told Bloomberg Law. He also said 2017 was a record year for generic drug submissions, not just FDA approvals.
But health-care attorney David Rosen said it’s encouraging that drug pricing and generic drugs are on President Trump’s mind. Rosen said generic drugs “can certainly hold down health-care costs” by giving people access to products that are high quality, therapeutically equivalent, and lower cost. Rosen is a partner and public policy lawyer with Foley & Lardner LLP, Washington, who previously held supervisory positions with the FDA. He also is a Bloomberg Law advisory board member.
Rosen said Gottlieb also has been working at the FDA to make generic drug products more widely accessible and more widely available and he’s been working with industry to make sure applications get through the approval process in a timely manner.
When asked whether the increase in approvals was due to his work or Gottlieb’s, Robert M. Califf, the previous FDA commissioner, told Bloomberg Law Jan. 31, “I like to think of it as a continuum. FDA is 17,000 people that are full-time, federal employees who do the work. Us commissioners come and go. And administrations come and go.”
“So I think there’s a good continuum and I think the really good news is that Scott is doing very well and I don’t think there’s been a major discontinuity in the policies,” Califf said.
The increase in approvals was due to both the administration and to a 2016 law, the 21st Century Cures Act, Janet Marchibroda, director of the Bipartisan Policy Center’s Health Innovation Initiative, told Bloomberg Law Jan. 31.
The Cures Act, a biomedical innovation law aimed at spurring development of new drugs and devices ( Pub. L. 114-255), provided a lot of tools and created a foundation by urging innovation and improvement at the agency, “but at the end of the day, it comes down to leadership and execution.”
A generic industry group also praised the president’s comments on generics and drug prices.
“The President’s commitment to lowering drug prices is encouraging to so many Americans, as is the recognition that generic and biosimilars medicines are key to solving this challenge,” Allen Goldberg, vice president of communications for the Association of Accessible Medicines, said in a statement provided to Bloomberg Law.
“We applaud the Administration prioritizing generic approvals, yet that is only a first step in containing prices since we must also ensure there is an accessible and sustainable market for generic and biosimilar medicines,” Goldberg said. Biosimilars are less expensive versions of complex, FDA-approved biologic drugs. The FDA has approved nine biosimilars under a 2010 law, but only three are being marketed so far.
--With assistance from Jeannie Baumann.
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