GENERIC DRUG ACCESS: Murray Calls for Improved Patient Access to Affordable Treatments

Continues push for sustained investment in FDA and NIH to help patients get safe, effective treatments and drive innovation

(Washington, D.C.) – Today, Senate Health, Education, Labor, and Pensions (HELP) Committee Ranking Member Patty Murray (D-WA) delivered opening remarks at a hearing on Accelerating Patient Access to Generic Drugs. Senator Murray emphasized the importance of helping patients get safe, affordable, high-quality treatments.

Senator Murray stressed the need for bipartisan work to improve families’ access to the best treatments and cures available and to build on progress made through the generic drug user fee program. She also discussed the importance of mandatory investments in the NIH and FDA as part of the Committee’s ongoing work to advance medical innovation for patients.

Key excerpts from Senator Murray’s remarks:

“Today’s hearing is also an important opportunity to discuss the related, larger issue of prescription drug access and affordability in our country. Nearly half of our country’s population—and the vast majority of our seniors—take prescription drugs. But families across the country have made clear that paying for prescription drugs is an increasingly unsustainable burden.”

“We are on the cusp of major breakthroughs in personalized medicine, and there is real momentum around tackling some of the greatest medical challenges of our time—like cancer and Alzheimer’s. And we have to ask ourselves how we are going to guarantee that we have the research, the market, and the access to ensure the benefits from that lifesaving progress are felt across the system as a whole.  We also have to make sure that insurers are covering their fair share.”

“In addition, if our goal is to ensure patients have access to—and can afford—the best, safest, most effective cures and treatments—we have to consider the resources we’re putting into this effort. Because the truth is, we simply can’t realize the goals of access, quality, and affordability without the FDA and the NIH at full throttle. If you want the FDA to be able to approve drugs more quickly, without rolling back the gold standard of consumer safety and protection, then the FDA is going to need more support to do its job. And if you want the NIH to be able to help drive innovation that delivers on so many patients and families’ hopes—that is also going to require sustained investment.”

“As we look for ways to improve health care for families, ensuring that prescription drugs are accessible and affordable must be a top priority. Finding solutions won’t be easy—but these are challenges that simply can’t be ignored. And I’m confident that if we all come to the table ready to join together, toward the common goal of ensuring our health care system works for families and puts their needs first, we can make real progress, and deliver results that so many families and communities are waiting for.”

Full text of Senator Murray’s remarks:

“Thank you, Chairman Alexander.

“Director Woodcock, thank you for taking the time to be here, and for all your work on behalf of families and communities nationwide.

“I’m pleased we have the opportunity today to discuss the FDA’s generic drug program.

“This program is absolutely crucial to helping patients get safe, affordable, high-quality treatments more quickly.

“Generic drug user fees have significantly improved the FDA’s ability to keep up with the large volume of generic drug applications.

“And it has helped build on the important work done in Hatch-Waxman to both incentivize innovation and expand families’ access to the best treatments and cures available.

“There is, of course, room for improvement.

“While it was certainly a big undertaking to establish this program on an aggressive timeline—I hope that going forward we can encourage more communication and efficiency. 

“It’s important to remember that both Hatch-Waxman and FDA programs like GDUFA are the result of strong bipartisan work.

“And as we move toward the reauthorization of the generic drug user fee program next year, it’s critical that our committee’s tradition of bipartisanship on these issues continues.

“And I’m looking forward to working with the Chairman and all of our colleagues to ensure the FDA has the tools and resources it needs to serve families and communities safely and effectively.

“Today’s hearing is also an important opportunity to discuss the related, larger issue of prescription drug access and affordability in our country.

“Nearly half of our country’s population—and the vast majority of our seniors—take prescription drugs.

“But families across the country have made clear that paying for prescription drugs is an increasingly unsustainable burden.

“Nationwide, spending on prescription drugs was nearly $374 billion in 2014—an increase of roughly 13 percent in just one year.

“And we expect to see continued cost growth.

“We need to face up to the tough questions.  For instance, how can we continue to afford to make critical new treatments widely accessible to patients who need them?

“Sadly, the status quo is working all too well for some bad actors at the very top—and they are doing everything but putting patients first.

“When someone like Martin Shkreli comes along to rig the system in favor of his profits above access, without regard to research investments or patient outcomes, we must act. 

“We are on the cusp of major breakthroughs in personalized medicine, and there is real momentum around tackling some of the greatest medical challenges of our time—like cancer and Alzheimer’s.

“And we have to ask ourselves how we are going to guarantee that we have the research, the market, and the access to ensure the benefits from that lifesaving progress are felt across the system as a whole.

“We also have to make sure that insurers are covering their fair share.

“We made important progress capping out-of-pocket spending as part of the Affordable Care Act, but there is more work to do to ensure that patients aren’t being saddled with too heavy a cost burden.

“And I am especially concerned that we must prevent carriers from discriminating against patients with the most expensive illnesses.

“In addition, if our goal is to ensure patients have access to—and can afford—the best, safest, most effective cures and treatments—we have to consider the resources we’re putting into this effort.

“Because the truth is, we simply can’t realize the goals of access, quality, and affordability without the FDA and the NIH at full throttle.

“If you want the FDA to be able to approve drugs more quickly, without rolling back the gold standard of consumer safety and protection, then the FDA is going to need more support to do its job.

“And if you want the NIH to be able to help drive innovation that delivers on so many patients and families’ hopes—that is also going to require sustained investment.

“I was extremely pleased that Democrats and Republicans were able to come together to boost support for the NIH through the spending bill last year.

“But I see no reason to stop there.

“In fact, as I’ve made clear—I believe as part of our committee’s effort to advance medical innovation for families, it is critical that we increase mandatory funding for the FDA and the NIH.

“And I hope that’s something we can continue to work on together.

“As we look for ways to improve health care for families, ensuring that prescription drugs are accessible and affordable must be a top priority.

“Finding solutions won’t be easy—but these are challenges that simply can’t be ignored.

“And I’m confident that if we all come to the table ready to join together, toward the common goal of ensuring our health care system works for families and puts their needs first, we can make real progress, and deliver results that so many families and communities are waiting for.

“Thank you.”