An initiative aimed at speeding the drug development process to ensure patients have faster access to innovative treatments, several provisions of the bill have received mixed reviews.
"Don’t Weaken the FDA’s Drug Approval Process," screams the title of a blog in The New York Times authored by a formed Comissioner of the FDA and 2 co-founders of a healthcare activist group.
The 21st Century Cures Act, the brainchild of a bipartisan partnership, received overwhelming approval of the House Energy and Commerce Committee about a month back. An initiative aimed at speeding the drug development process to ensure patients have faster access to innovative treatments, several provisions of the bill have received mixed reviews.
In the blogpost, the authors warn against providing access to drugs that have not been thoroughly evaluated for their safety or long-term outcomes, which they say would unnecessarily place the patient at risk. Citing an example of the partnership between AIDS activist groups and the FDA in the 80s, which provided patients with quicker access to experimental drugs, the authors explain that the FDA "transformed itself into a more flexible and creative institution that has introduced new ways to speed lifesaving treatments to patients," while ensuring that the manufacturers monitor drug safety and efficacy. The product of these efforts were the treatment-revolutionizing protease inhibitors that saved thousands of lives.
The authors warn that the Cures bill opens the door to lowering the rigorous standards that the FDA demands manufacturers maintain with their products, that ensure public safety. An example of would be the provision that would allow clinical experience to replace scientific data from large well-controlled clinical trials in the drug approval process. Another example they cite is allowing less rigorous standards for medical devices like heart stents.
Innovation breathes life into healthcare, as has been proven time and again. But innovation without standardization and validation would do more harm than good.
Beyond Insulin: The Impact of Next-Generation Diabetes Technology
April 17th 2024Experts explain how new diabetes technologies like continuous glucose monitors are transforming care beyond intensive insulin therapy, offering personalized insights and improving outcomes for patients of all treatment levels.
Read More
Overcoming Employment Barriers for Lasting Social Impact: Freedom House 2.0 and Pathways to Work
April 16th 2024To help celebrate and recognize National Minority Health Month, we are bringing you a special month-long podcast series with our Strategic Alliance Partner, UPMC Health Plan. Welcome to our second episode, in which we learn all about Freedom House 2.0 and the Pathways to Work program.
Listen
Age Alone Is No Barrier to Allo-HCT for AML, Data Indicate
April 17th 2024A new study is among the largest real-world analyses to date to assess trends over time and predictive factors for older patients with acute myeloid leukemia (AML) who received allogeneic hematopoietic cell transplantation (allo-HCT).
Read More
Making Giant Strides in Maternity Health Through Baby Steps
April 9th 2024To help celebrate and recognize National Minority Health Month, we are kicking off a special month-long podcast series with our strategic alliance partner, UPMC Health Plan. Welcome to our first episode, which is all about the Baby Steps Maternity Program and its mission to support women throughout every step of their pregnancy journey.
Listen
Need for Pharmacogenomic Testing in Mental Health Care Explored at AMCP 2024
April 17th 2024Presenters from Mayo Clinic discussed the benefits of implementing pharmacogenomic testing in mental health care for the betterment of patient outcomes, reducing medical costs, and more at the Academy of Managed Care Pharmacy (AMCP) 2024 annual meeting.
Read More