The Biden administration is facing mounting pressure to take a direct hand in lowering drug prices and increasing access, with
Advocates behind the Make Meds Affordable campaign want the Health and Human Services Department to use existing levers to take down “patent monopolies” and make drugs more affordable, according to a Thursday petition lodged with the agency. The petition is billed as a workaround while Congress hammers out drug pricing legislation.
“HHS does not need to wait for Congress to begin lowering drug prices,” Peter Maybarduk, director of Public Citizen’s Access to Medicines program, said in a statement. Public Citizen is among the advocacy groups behind the campaign.
“Challenging pharma today will give the government leverage, deliver affordable medicines and increase the benefits of drug price negotiation in the near future,” he said.
A debate is raging around the Biden administration’s ability to push down drug prices without help from Congress. The petitioners say the government has two legal mechanisms at its disposal: “march-in rights” and “government patent use.”
March-in rights allow the government to license a private company’s patents to outside entities if the government helped fund the invention’s research and development. Government patent use under 28 U.S.C. §1498 allows the government to sign off on generic competition if it compensates the company holding the patents.
In the case of Pfizer’s Paxlovid, the advocates argue the government “can provide a letter authorizing generic manufacturers for government procurement, thereby providing the shield of Section 1498 if and when patent applications mature into issued patents.”
“In doing so, the U.S. government can reduce prices, increase supply, and help protect more Americans from COVID-19,” the petition said.
The federal government bought 20 million courses of Pfizer’s drug for $530 a course, but the product “is currently in shortage,” the petition said. It noted that while Pfizer is expected to up supply, there may still not be enough doses to go around.
“The generic manufacturers coming online are not currently planning investments with the U.S. market in mind. Pfizer retains a de facto monopoly,” the advocates added.
Sen. Elizabeth Warren (D.-Mass), other lawmakers recently threw their support behind an effort to convince the government to license patents on Astellas’ cancer drug Xtandi to outside manufacturers to produce the medicine. That effort is facing stiff opposition from nearly 100 interest groups and individuals casting the idea as misusing law and threatening public-private partnerships like those that led to Covid-19 therapies and treatments.
Xtandi is one of six medicines listed in the Make Meds Affordable petition, along with insulin and
CPD Action, Social Security Works, People’s Action and PrEP4All are among the advocacy groups backing the campaign.