The president’s directive also urges the Federal Trade Commission to promote the availability of generic drugs by banning pharmaceutical manufacturers from paying their generic counterparts to delay entry of lower-price versions of medications into the market.
Such a ban is consistent with Biden’s support during his campaign for increasing the supply of generics. The idea is also part of legislation before the Senate.
“Just a handful of companies control the market for many vital medicines, giving them leverage over everyone else to charge whatever they want,” the president said during remarks in the White House’s State Dining Room before a signing ceremony. “As a result, Americans pay two and a half times more for prescription drugs than any other leading country.”
The president also said hearing aids should be available to buy over the counter at pharmacies, rather than mainly from hearing specialists — a change he predicted would lower their cost and lead more people with hearing loss to use them.
In addition, Biden’s directive seeks to promote competition among hospitals and health insurers, with a goal of making care more affordable.
The health-care portions of Biden’s order come among 72 initiatives spanning more than a dozen federal agencies that the president folded into the directive, which is a broad exhortation for the government to foster more competitive practices.
The sections of the order addressing health care represent an imprimatur of the values and goals for the administration’s work in that realm, rather than a set of unfamiliar new policies.
One aspect directs the Department of Health and Human Services to produce a comprehensive plan in the next 45 days to combat high prescription drug prices.
The idea of an administration plan on drug costs exceeds Biden’s previous calls for Congress to take action this year to constrain pharmaceutical prices — an issue of substantial concern among voters. The order does not indicate what the plan should contain or whether it should lead primarily to a law enacted by Congress or to rules within the power of the executive branch, according to one person familiar with the order.
The part of the order involving health coverage directs HHS to revive a rule for health plans sold within the Affordable Care Act’s federal insurance marketplaces. The Obama administration required insurers selling in ACA marketplaces to offer at least one option with a standard benefit design to make it easier for consumers to compare plans from different insurers. Such standard benefits were part of marketplace plans in 2017 and 2018, but the Trump administration removed that requirement as of 2019.
Friday’s directive does not specify when that will be restored, but it will not be for the coming year, according to a federal health official who described this part of the order on the condition of anonymity before it was signed.
The order contains language condemning the effects of hospital consolidations that have swept the nation in recent years. It cites research showing hospitals in consolidated markets tend to charge more than those with greater competition, and it says the trend has contributed to the closing of hospitals in some rural communities.
Biden is directing the Justice Department and the FTC to “review and revise their merger guidelines,” with a goal of preventing patients from being harmed when hospitals combine. It does not specify ways in which those guidelines should be changed.
The main trade association of for-profit hospitals pushed back against the potential for stronger antitrust actions, a theme Biden emphasized in his remarks.
“It is chasing a mirage to think that patient access and choice in health care can be achieved through constraining integration of health-care services,” said Charles N. “Chip” Kahn III, president of the Federation of American Hospitals.
Biden says his administration should continue to move forward with controversial recent rules that compel hospitals to disclose the prices they negotiate in private with insurance companies.
The idea of lowering drug prices by importing medicines from Canada has been controversial since it was included in a 2003 law that added drug benefits to Medicare, the federal health insurance for older Americans. The law said the importation could happen but the HHS secretary must first certify it would be safe. No secretary did that until Alex Azar, Trump’s longest-serving health secretary, authorized it last year.
Unlike many Republicans, Trump favored importation, and his administration finalized a rule last year allowing states to ask the Food and Drug Administration, part of HHS, for permission. Florida became the first state to apply, and the FDA has not decided whether to approve its request.
Meanwhile, the Pharmaceutical Research and Manufacturers of America, a powerful industry group, sued HHS seeking to block drug imports. The litigation began last year while Trump was president, but the Biden administration is now part of the case, trying to get it thrown out of court.
Biden’s order makes clear that his administration favors the importation rule of his predecessor and that he expects the FDA to carry it out.
Reacting to the president’s directive, PhRMA’s president, Stephen J. Ubl, did not explicitly mention importation but said in a statement, “Today America’s patients benefit from the world’s most competitive market for prescription drugs.”
Ubl said the association favors “common sense solutions that would lower out-of-pocket costs for patients,” but he alluded to previous industry objections against purchasing drugs from Canada, saying the group opposes policies that “risk the health and safety of patients or undermine[s] future innovations.”