Bill Introduced to Reduce Prescription Drug Companies Exclusivity Period
WASHINGTON, DC – Yesterday, Representatives Jan Schakowsky, Rosa DeLauro, Angie Craig, Lloyd Doggett, Raja Krishnamoorthi, and Andy Levin held a press conference to discuss H.R. 3379, the Price Relief, Innovation, and Competition for Essential Drugs (PRICED) Act, sending a clear message that Congress intends to change U.S. laws to lower drug prices, and that current negotiations by the Trump Administration around the United States-Mexico-Canada Agreement must not create any barriers in achieving that goal. The PRICED Act addresses one of Big Pharma’s most effective price gouging tools by reducing the exclusivity period for biologics from twelve years to five years.
“Big Pharma has told us again and again that biologics are especially costly to develop and manufacture because of time and complexity. They have demanded unique protections to supposedly recoup their investments. But we know that those claims are just another price gouging tool that have resulted in billions upon billions of profits as Americans struggle to afford drugs they need to survive,” said Congresswoman Schakowsky, who has been selected to co-lead the medicines negotiations of the House Democrats’ Trade Working Group. “The USMCA as it stands now would keep drug prices out of reach for patients by locking in 10 years of marketing exclusivity for biologics. If ratified, that language would stand in the way of Congress’ ability to pass bills like my PRICED Act, which would increase competition and enhance patient access to more affordable prescription drugs.”
“The PRICED Act will expand competition and lower prescription drug costs for patients, seniors, and families,” said Congresswoman DeLauro. “Americans are suffering under the crushing weight of prescription drug costs, which continue to become more and more unbearable. Seniors should not have to choose between putting food on the table and filling their prescriptions—and we cannot turn a blind eye or simply stand by. This issue also has an important component with regard to trade. The renegotiated NAFTA provides pharmaceuticals at least 10 years of marketing exclusivity for biologic drugs and would block the Congress from taking action on behalf of families and patients with legislation liked the PRICED Act. That is why we are fighting to ensure that any new NAFTA does not lock in such a giveaway.”
Many recent peer-reviewed studies suggest that biologics are not as time-consuming to develop as initially believed. On Tuesday, authors from the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, and Harvard Medical School published a study in Nature that concluded “although biologics are often thought to be more time-consuming to develop than small-molecule drugs, development times for biologics are similar to, or possibly somewhat shorter than, for small-molecule drugs.”
“For far too long, brand-name pharmaceutical companies have been profiting at the expense of Minnesota families by blocking competition which makes life-saving drugs unaffordable,” said Rep. Craig. “I’ve spoken with folks across my district who all say the same thing: they need Congress to take action on prescription drug costs now. I’m proud to be a champion for lowering costs to ease the burden of prescription drug prices on Minnesota families.”
“Prices have risen hundreds and even thousands of percent since the original NAFTA was adopted. And just as Trump’s domestic agenda has done so little to provide protection from pharmaceutical price-gouging, his trade policy is much worse. We must urgently address the unjustified level of protection for brand biologics. We’ve got to break the monopoly—and that begins with the PRICED Act and ensuring the USMCA is changed. Not only must we protect the public policy space of today, but we must also think about tomorrow,” said Rep. Doggett.
Rep. Krishnamoorthi added, “I’m proud to join with my colleagues on this much-needed legislation to bring down the high price of prescription drugs. Through reducing the exclusivity period for biologic drugs, we can increase competition and decrease prices for consumers and working families.”
“I think just about every family has had to deal with outrageously high drug prices, and mine is no different,” Congressman Andy Levin said. “I’m a two-time cancer survivor, and I have two sons with Crohn’s disease. I know there’s not a parent out there who wouldn’t do anything to keep their kids healthy—even if it means skipping necessities for themselves. It should not be this hard. I support the PRICED Act because I want to make drugs more affordable. I also support trade deals that work for working families. And, right now, the NAFTA rewrite that the Trump Administration is pushing just doesn’t cut it.”
Endorsing organizations of the PRICED Act include a robust group of advocacy, labor, and industry stakeholders: Patients for Affordable Drugs Now, Families USA, the National Committee to Preserve Social Security and Medicare, Alliance for Retired Americans, Center for Medicare Advocacy, Medicare Rights Center, Public Citizen, Social Security Works, American Federation of Teachers, United Automobile Workers, International Association of Machinists and Aerospace Workers, Communications Workers of America, United Steelworkers, and CVS Health.