Personalized Medicine Education and Advocacy

Thought leadership in personalized medicine

An Infrastructure for Innovation: How the 21st Century Cures Bill Established a More Favorable Landscape for Personalized Medicine in 2017

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by Daryl Pritchard, Ph.D., Vice President, Science Policy

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Daryl Pritchard, Ph.D.

Barack Obama’s administration was clearly committed to the advancement of personalized medicine.  In addition to launching the Precision Medicine Initiative and the Cancer Moonshot effort, during his tenure President Obama regularly described personalized medicine as the future of health care.

“I want the country that eliminated polio and mapped the human genome to lead a new era of medicine, one that delivers the right treatment at the right time,” he said in his 2015 State of the Union Address.

The election of Donald Trump as the 45th President has led to a great deal of uncertainty on the future of personalized medicine and the fate of Obama’s signature personalized medicine programs.

Fortunately, Congress has confirmed its support for personalized medicine by passing the 21st Century Cures Act.  The law, designed to accelerate the pace of biomedical innovation, a goal that President-elect Trump has expressed interest in, provides continued momentum for personalized medicine. The House of Representatives voted 392 – 26 in favor of the legislation one week before the Senate passed the law 94 – 5. President Obama is expected to sign it.

“The 21st Century Cures bill supports personalized medicine,” PMC President Edward Abrahams said. “The Precision Medicine Initiative, the Cancer Moonshot and speedier access to innovative therapies based on molecular pathways, in particular, will all contribute to a healthier nation.”

Among other things, the bill:

  • Authorized $4.8 billion in funding over 10 years for programs at the National Institutes of Health (NIH) that include the All of Us Research Program and the Cancer Moonshot Research Program, as well as $500 million for FDA to implement provisions to improve innovation
  • Required FDA to make the patient experience a more central part of the drug development process
  • Established a review pathway at FDA for biomarkers and other drug development tools
  • Included provisions related to FDA’s oversight of diagnostics, albeit without addressing the longstanding debate on the regulation of laboratory-developed tests
  • Modernized clinical trial design and evidence development as it relates to the consideration of real-world data and other topics
  • Required FDA to pilot one or more inter-center institute(s) to help develop and implement processes for coordination of activities in major disease areas between the drug, biologics and device centers
  • And enhanced the country’s capacity to deliver personalized medicine through improvements and incentives in health information technology.

The law is not perfect. Policymakers have pointed out, for example, that the amount of NIH funding is half of what was proposed in the 2015 version, and that the programs are authorized rather than appropriated, thereby not guaranteeing that they will be funded. Others object to using the Affordable Care Act’s prevention funds to pay for Cures provisions.  Furthermore, although proponents claim the law’s new measures will not weaken FDA’s regulatory oversight, some critics disagree, especially regarding regenerative medicine.

But despite these concerns, the 21st Century Cures Act has provided a more favorable setting for personalized medicine amid ongoing uncertainty under a new administration.

The Personalized Medicine Coalition applauds Congress for passing the legislation and delivering it to the President, who has indicated his strong support for its provisions.  By allocating resources for personalized medicine programs and encouraging biomedical innovation, the 21st Century Cures Act will help drive personalized medicine’s enormous potential for patients and the health system in a future that otherwise remains uncertain.

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