We wanted to make you aware of an opportunity to submit public comments to the Food and Drug Administration (FDA). Specifically, the FDA would like the public’s views on two main issues:
- What criteria the FDA should use to evaluate new opioids to treat pain
- What new incentives are needed to better support and encourage the development of new treatments for pain
On Sept. 17, the FDA held a public hearing called “Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction.” While the public hearing has passed, the FDA is accepting written comments until Nov. 18 at 11:59 pm EST.
Being a pain warrior means fighting for positive change. Right now, there are two major opportunities to comment on the state of pain care in America at the highest levels of the U.S. government: the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA).
Opportunity #1: HHS Interagency Pain Management Best Practices Task Force – second meeting
Deadline: Sept. 17
How to take action: Submit comments here
Cindy Steinberg, National Director of Policy and Advocacy, was one of the numerous people with pain to speak at the the Food and Drug Administration (FDA)’s “Patient-Focused Drug Development Public Meeting on Chronic Pain” on July 9. The event drew an at-capacity audience in the auditorium, on the phones, and through a web portal. Dr. Sharon Hertz, Director of the FDA’s Division of Anesthesia, explained to the crowd that she and her colleagues were there to better understand the impact of chronic pain, patient perspectives on current treatment regimens, and the challenges or barriers patients face in accessing treatment.
After a two-year process calling on New York State lawmakers to update patient protections surrounding biologic treatments, U.S. Pain Foundation is pleased to announce that Gov. Andrew Cuomo signed a biologic substitution bill, Chapter 357 of the Laws of 2017.
Earlier in the state’s legislative session, U.S. Pain reached out to senators and the Assembly, urging them to support Senate Bill 4788 and its companion bill. The legislation secured effective medication substitution laws while also allowing patients to access this new age of medicines in a safe, reliable, and consistent manner.
On April 5, U.S. Pain Foundation’s Senior State Advocate, Wendy Foster, flew to D.C. for the joint meeting of the Anesthetics and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management at the Food and Drug Administration (FDA). The meeting was held to determine if a new drug met the parameters to be considered an abuse-deterrent formula (ADF). ADFs are a special type of pain medications that cannot be crushed, snorted, or otherwise manipulated, making them difficult to abuse.
U.S. Pain Foundation spoke out on two important federal issues this month with articles in the National Pain Report. The first article, published Jan. 11, discussed the potential Affordable Care Act (ACA) repeal, while a second article highlighted new biosimilar and biologic naming guidelines and was published Jan. 24.
In the ACA story, U.S. Pain joined many other patient advocacy organizations in expressing concern over the potential repeal without details for a replacement. Written by Shaina Smith, director of advocacy and alliance development, on behalf of U.S. Pain, the article emphasized the importance of access to quality, affordable insurance for chronic pain patients.