White House March-In Plans Must Go Further to Challenge Big Pharma’s Monopoly Power

The White House today announced plans to support medicine affordability, including guidance for the longstanding controversy of “march-in rights,” by which federal agencies can authorize price-cutting generic competition with expensive publicly-funded patented medicines under the Bayh-Dole Act. Public Citizen has co-signed many march-in petitions to the federal government, with consumer groups including Knowledge Ecology International, calling for use of march-in rights to promote access to medicine when patented drugs are priced unreasonably. Earlier this year, the Biden administration turned down a petition from cancer patients to march-in on patents for the expensive prostate cancer drug Xtandi, which is priced far higher in the United States than in other high-income countries. Public Citizen’s Access to Medicines director Peter Maybarduk issued the following statement:

“March-in can be, should be, a powerful tool to support fair pricing and access to publicly-funded medicines, as President Biden importantly suggests. Unfortunately the administration’s march-in policy is far more limited than the statute allows. It should be quickly revised to recommend use of march-in wherever publicly-funded medicines are unreasonably priced.

“We appreciate the White House spotlighting patent abuse and indicating that high prices can give cause for exercising march-in rights.

“But the framework proposed today is far too restrictive. It considers cases of ‘extreme, unjustified and exploitative’ pricing, presumably measured against the already-outrageous commonplace pharma price abuses of the day, under which Americans are routinely charged two to four times more for drugs than patients in other wealthy countries.

“Where most drug prices already are egregious and force rationing, few drugs will seem ‘extremely’ priced by comparison. Federal agencies have shown themselves reluctant to act against unreasonable prices, and this new proposal may give them permission to continue to do nothing.

“The examples the announcement offers evade the main and important use case: where drug corporations abuse their monopoly power to charge exorbitant prices, ignore the government contribution to R&D and charge Americans more than people in other countries. The final guidelines must be adjusted so they explicitly cover these scenarios and establish common-sense criteria for what constitutes an unreasonable price. Falling short risks doing nothing to lower the prices of taxpayer-funded medicines for patients, and instead perpetuating an unacceptable status quo. Americans have a right to expect not to be price gouged for medicines they paid for in the first place.”