The president told drugmakers he plans to cut regulations by at least 75%.
Last week, Donald Trump told top pharmaceutical executives he wanted to slash regulations to help them get more drugs approved faster. “We’re gonna get rid of a tremendous number of regulations,” he declared. “The problem with the regulation that we have right now is that you can’t do anything. You can’t, I have people that tell me they have more people working on regulations than they have doing product.”
Trump has promised to slash Food and Drug Administration guidelines by 75% to 80% and to nominate an FDA head who would speed up the drug development process. (The front-runner, Scott Gottlieb, is a doctor, which is traditional for the role—but two other contenders are venture capitalists.)
But some experts worry that Trump’s focus on slashing rules is wrong-headed—and possibly dangerous: “He’s been bamboozled by Big Pharma into thinking that the high price of drugs is because of regulations and because drug companies are paying so much for research and development,” says Matthew Kavanagh of Health GAP, which advocates for affordable HIV/AIDS drugs. “Yet for critical AIDS drugs, it’s actually taxpayers that have paid for much of the drug development through government grants. But drug companies get the profits because they have patent monopolies.
Kavanagh says Trump was right about one thing: “The way to drive down drug prices is to import generic versions of these drugs to allow for competition. This is why AIDS drugs are available for so much cheaper outside the United States—because they encourage real market competition.”
And, much to the worry of Big Pharma, Trump has actually kept up his drumbeat about forcing drugmakers to lower prices, including letting Medicare negotiate the price of drugs directly—which a 2003 law currently forbids it from doing. Trump says prices are “astronomical” and complained that pharmaceutical companies are “getting away with murder.”
Even in the absence of a vaccine or cure, the current state of HIV drugs is very good—with multiple rounds of highly effective options for patients to choose from.
Of course, if Trump and the GOP carry through with their plans to repeal Obamacare and slash Medicaid, with no equal or better coverage alternative in sight, access to those drugs may become much harder for many Americans with HIV/AIDS. They may be thrown back onto the AIDS Drug Assistance Program (ADAP), whose quality varies by state. Many patients on ADAP faced long waiting lists for lifesaving drugs pre-Obamacare, especially in red states. And it won’t be surprising if domestic HIV/AIDS care is not a priority of the Trump administration, which recently took down the website for the Office of National AIDS Policy.
Killing or cutting Obamacare and Medicaid could also limit access to PrEP, which has played a significant role in decreasing the number of new infections. Of course there is no telling yet what the Trump administration might try to do to The United States President’s Emergency Plan for AIDS Relief (PEPFAR), which was started under President George W. Bush and gets HIV drugs to poor countries. (Just-confirmed Secretary of State Rex Tillerson has voiced support for the program, though.)
But when it comes to cutting regulations for new drugs, experts who’ve long focused on HIV-drug access and pricing are alarmed. “There’s a real risk of actual harm,” Peter Maybarduk of Public Citizen told NewNowNext. “The FDA ensures that meds that come on the market are safe and effective for their listed purpose. We don’t want people spending their life savings on drugs that don’t work.”
If anything, he says, the FDA should be regulating more, particularly after drugs come to market. Maybarduk points to the now-discontinued painkiller Vioxx, which was approved but then caused tens of thousands of heart attacks, many of them fatal. Or the flu drug Tamiflu, which the government stockpiled at a cost of billions to taxpayers, only for further study to find it a failure.
Current obligations to report data after a drug comes to market, says Maybarduk, “are weak.”
Then again, easing up on regulations remains a moot point until Trump has someone in place at the FDA. Until then, the immediate crisis for millions of Americans with HIV/AIDS and myriad other chronic conditions is the possible end of Obamacare and reduction of Medicaid.
That’s why Republican congressmembers nationwide are being swarmed by campaigns like this in which constituents are testifying as to how the programs have kept them alive and well.