Bilirakis Introduces the PATIENT Act to Improve Medications
Washington, D.C. – Representative Gus Bilirakis (R-FL), today introduced H.R. 1353, the Promoting Access for Treatments Ideal in Enhancing New Therapies (PATIENT) Act, with his colleagues Representative Gerry Connolly (D-VA), Representative Morgan Griffith (R-VA), and Representative Steven Israel (D-NY). The PATIENT Act would incentivize drug manufacturers by allowing for an additional 24 months of market exclusivity for a medication, if they are able to improve a medication to create FDA-approved new therapeutic entities. These improvements could include enhanced safety, patient adherence, fewer side effects or new indications.
"Imagine a patient suffering from Huntington's disease, who, thanks to improvements to her or his medication, only has to take a pill once a week instead of everyday. Imagine a cancer patient, whose medication has less severe side effects, improving her or his quality of life. Or imagine a patient whose opioid included an abuse deterrent, so it would be more difficult for an addict to abuse the drug. These would be truly life-changing innovations, and that is what the bipartisan PATIENT Act does," said Bilirakis.
"Innovations to medications can ensure that patients more regularly take their medicines and improve their impact on the health of all Americans. We must make that happen," continued Bilirakis.
"By redesigning or reformulating existing medicines, researchers are discovering the untapped potential for those medicines to treat other chronic diseases and conditions and advance alternate, less costly methods for delivering treatments," Connolly said. "This common-sense legislation would further incentivize these efforts, which already are improving patient outcomes and have the potential to produce additional breakthroughs."
"The PATIENT Act is commonsense policy that simply provides the FDA with authority to review and recognize significant improvements upon previously approved therapies. This legislation has the potential to incentivize innovation of existing treatments by improving upon their effectiveness, efficiency, and safety," Griffith said. "Patients, especially those with terminal illnesses, deserve faster and better cures, and this bill is a solid step towards achieving this goal."
"This bipartisan legislation provides the right incentives for researchers to invest time and money into developing momentous improvements to drugs that are already in the market. If we can find ways to make treatments safer and more effective for patients with Alzheimer's or cancer Congress shouldn't hesitate to act," said Israel.
The PATIENT Act is also included in the 21st Century Cures draft legislation. You can read the text here, and a summary of the provisions here.
The following organizations support the PATIENT Act:
- Huntington's Disease Society of America
- National Alliance on Mental Illness
- Tuberous Sclerosis Alliance
- U.S. Pain Foundation
- American Academy of Pain Management
- Allergy and Asthma Network