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Legislation that aims to lower prescription drug prices by allowing Americans to import medicine from Canada was introduced Feb. 28 by Sens. Bernie Sanders (I-Vt.), Cory Booker (D-N.J.) and Bob Casey (D-Pa.).
The Affordable and Safe Prescription Drug Importation Act also would authorize the health and human services secretary in two years to allow importation from other advanced countries. Reps. Elijah E. Cummings (D-Md.) and Lloyd Doggett (D-Texas) introduced a companion bill in the House.
Drugmakers are under heavy scrutiny by lawmakers, consumers, medical professionals and the president for their pricing practices. President Donald Trump Jan. 31 told drugmakers at a White House meeting they are charging too much for their products.
“Drug companies make enormous profits, their CEOs enjoy high compensation packages but the American people can’t afford the prescriptions they need,” Sanders said in a press briefing. “Bottom line is the same exact medicine made in the same exact factory is sold at substantially lower prices in Canada.” The bill “would make certain that medicine coming into this country is 100 percent safe.”
The bill includes safety provisions such as requiring imported drugs to be purchased from a foreign seller certified by the Food and Drug Administration. The bill also wouldn’t allow importation of controlled substances, anesthetic drugs inhaled during surgery or compounded drugs.
Cummings said at the briefing “this is a bipartisan issue” and “we’re focusing on ideas that even President Trump said he supports.”
“Trump said he was going to bring down drug prices and warned that the pharmaceutical industry is getting way with murder. Words are nice, but people need relief,” Cummings said.
Cummings also said he plans to meet with Trump next week on drug prices.
Bloomberg Intelligence analyst Brian Rye told Bloomberg BNA in an e-mail that the legislation “is unlikely to garner sufficient traction on a stand-alone basis, though the must-pass bill to reauthorize the FDA’s drug and device user fee programs later this year may present a potential legislative vehicle for this and other measures aimed at drug pricing.”
Congress is preparing to consider legislation to reauthorize the laws governing industry-paid user fees, which help fund the FDA. All of the FDA’s user fee programs expire Sept. 30. After that time, new legislation will be needed to reauthorize the programs for fiscal years 2018 through 2022.
The agency has separate fee programs for prescription drugs, generic drugs, biosimilars and medical devices.
Nicole Longo, a spokeswoman for the Pharmaceutical Research and Manufacturers of America (PhRMA), told Bloomberg BNA in a Feb. 28 e-mail the legislation “would put U.S. patients in harm’s way.”
The bill “lacks sufficient safety controls, would exacerbate threats to public health from counterfeit, adulterated or diverted medicines, and increase the burden on law enforcement to prevent unregulated medicines and other dangerous products from harming consumers,” Longo said. “An importation scheme would open new avenues for unscrupulous organizations and individuals to take advantage of American patients.”
Longo said the FDA “has a strong system of checks and balances to keep the U.S. medicine supply safe. Yet this proposal permits the distribution of drugs outside of FDA’s jurisdiction—circumventing the agency’s robust safety requirements.”
Longo said U.S. patients “would be left to trust that foreign sellers and importers are truthful and in compliance without any assurance from FDA and without any means for FDA to check or take enforcement action if needed.”
Also, “there would be no way to trace the country of origin for the imported products,” Longo said. “Even Canada has said it does not and would not be able to guarantee that U.S. citizens would receive products that are safe, effective and of high quality. Guaranteeing patient safety is crucial, and we must have policies that ensure patients safely have access to the medicines they need.”
The Partnership for Safe Medicines (PSM) also said in a Feb. 28 statement provided to Bloomberg BNA the bill “puts the safety of the U.S. drug supply at risk. Nothing in this measure changes the fundamental fact that it would expose Americans to dangerous counterfeit and gray market pharmaceuticals. For decades, Health and Human Services Secretaries and Food and Drug Administration Commissioners have opposed drug importation because it plays politics with the health of every American.”
The PSM also sent a letter Feb. 28 to all members of Congress urging them to oppose proposals that would allow drug importation.
The PSM is a public health group comprising nonprofit organizations that is committed to the safety of prescription drugs and protecting consumers against counterfeit, substandard or otherwise unsafe medicines.
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The bill is at http://www.sanders.senate.gov/download/drug-importation-bill?inline=file and a summary of the bill is at http://www.sanders.senate.gov/download/drug-importation-bill-summary-and-background?inline=file.
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