2017-03-01

In his 1st address to Congress, President Donald Trump called for speeding up drug approvals within the FDA. Earlier that day, Sen. Bernie Sanders (I-Vermont) proposed a bill to allow the importation of prescription drugs from Canada in the hopes of lowering drug prices.

The new administration has been critical of drug prices, with Trump saying that pharmaceutical companies are “getting away with murder” in reference to what they charge government-funded programs for their drugs. Politicians, including Sanders and Rep. Elijah Cummings (D-Md.), appear to be looking for ways to work with the new president on this issue.

“We’re attacking this problem by focusing on ideas that even President Trump says he supports,” Cummings said. He is the sponsor of the companion bill in the House. “The president’s support for these ideas have been so clear that I’m tempted to introduce a bill in the House named ‘The Donald Trump Drug Affordability Act.’ I’m sure he would like that.”

The bill would require that foreign sellers register with the FDA and patients provide a prescription to the Canadian pharmacy that they’re buying from. The bill also grants the FDA the authority to shut down “bad actors”, hoping to address some of their colleagues’ safety concerns.

Last month, politicians voted on an amendment that would have allowed patients to buy prescription drugs from Canada and it won the support of 12 Republican senators, including Sen. John McCain (R-Ariz.). The amendment didn’t pass and opponents, including Sen. Cory Booker (D-N.J.) cited safety concerns.

Booker, a co-sponsor on Sander’s bill, reportedly said that his safety concerns are addressed in the newly-proposed bill.

“Do we expect the pharmaceutical industry will spend an enormous sum of money to oppose this? Of course we do,” Sanders said. “This is the time. The American people are sick and tired of getting ripped off, and we’re going to win this thing.”

Alongside efforts to rein in drug prices, Trump reinforced his hopes to improve FDA regulatory pathways when he introduced Megan Crowley at his address last night. She suffers from Pompe disease, a rare, genetic condition that degrades muscle.

“Our slow and burdensome approval process at the Food and Drug Administration keeps too many advances … from reaching those in need,” Trump said. “On receiving this news [of his daughter’s illness], Megan’s dad, John, fought with everything he had to save the life of his precious child.  He founded a company to look for a cure, and helped develop the drug that saved Megan’s life. If we slash the restraints, not just at the FDA but across our government, then we will be blessed with far more miracles like Megan.”

The president & CEO of the Medical Device Manufacturers Association, Mark Leahey, said in prepared remarks that the organization was excited by Trump’s comments and that it hopes to see a full repeal of the medical device tax.

“MDMA applauds President Trump’s call for a new generation of cures and therapies to improve patient care, and medical technology entrepreneurs stand ready to boost innovation and job creation,” Leahey said. “Medical technology innovators have a proud tradition of creating good paying jobs, but they need the proper policies in place to continue doing so.  Fully repealing the medical device tax, establishing a more transparent and predictable regulatory process, lowering corporate taxes and properly reimbursing medical technologies would create an environment that allows this proud American industry to thrive. Policy makers are well aware of the challenges confronting our health care delivery system and our economy, and it is critical that they enact legislation that will that create a framework to solve them.  Med tech innovators are at the forefront of developing new cures and therapies to address chronic conditions and rare diseases, and we must support this important work. MDMA and the medical technology industry look forward to working with President Trump, Congress and all stakeholders to achieve our common goals of strengthening the economy, patient care and our entire health care ecosystem.”

The post Trump calls for speedier approval process, while Sanders takes aim at drug prices appeared first on MassDevice.

Show more