Can you trust comments online? Not always, according to the Washington Post, which revealed that among 1,400 comments on proposed cuts to a drug discount program many comments were duplicates or exact copies. A panel examined biosimilars and listened to the public’s questions and concerns, and in Washington, Trump’s health chief met with GOP lawmakers on the push to lower drug prices. These top stories and more in the Innovation Partners BioBlog this week.
Copycat comments, unwitting patients become part of federal rulemaking process
A proposal to cut a drug discount program that hospitals rely upon drew sharp criticism last year, but how much of that criticism was valid? An analysis of 1,400 comments revealed that many were duplicate comments and appeared to be copycat responses. Is this legitimate pushback or a carefully choreographed response? A look at a peculiar situation around response to the federal rulemaking process.
Loxo Oncology Announces Receipt of Breakthrough Therapy Designation from U.S. Food and Drug Administration for LOXO-292
Loxo Oncology, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to LOXO-292, a selective RET inhibitor, for the treatment of patients with metastatic RET-fusion-positive non-small cell lung cancer who require systemic therapy and have progressed following platinum-based chemotherapy and an anti-PD-1 or anti-PD-L1 therapy and for the treatment of patients with RET-mutant medullary thyroid cancer who require systemic therapy, have progressed following prior treatment and have no acceptable alternative treatment options.
FDA’s Public Hearing on Biosimilar Action Plan Draws Wide Stakeholder Involvement
FDA and Center for Drug Evaluation and Research (CDER) representatives presided over a panel to hear comments on the Biosimilar Action Plan released earlier this year. The representatives heard from the public and 27 speakers on concerns and questions related to the use of biosimilars. A look at frequently asked questions and themes from the hearing.
Administration Urged to Protect Patient Access to Cancer Treatments in Meeting on Drug Pricing
ASCO recently urged the Trump Administration to avoid creating any barriers to cancer care as policies within the drug pricing blueprint are implemented. ASCO also offered alternative options to address the cost of cancer drugs, while maintaining the quality of cancer care, including oncology clinical pathways.
Study: More Than 14,000 Americans Die Each Year From This Preventable Cancer
More than 14,000 Americans die each year from colon cancer, a highly preventable form of cancer. The author of this article urges more Americans to receive colon cancer screenings. Death rates decrease as screening rates increase, demonstrating that early detection and treatment saves lives.
Federal court nixes CMS overpayment rule, handing a big win to Medicare Advantage insurers
The Federal Court struck down a rule requiring payers to report and return overpayments. This ruling could have significant impacts on Medicare Advantage insurers. U.S. District Judge Rosemary Collyer in D.C. sided with UnitedHealth, which argued the rule that requires MA plans to return overpayments based on an analysis of its members’ health status was “wholly inconsistent” with Medicare fee-for-service requirements.
Trump health chief meets with GOP lawmakers on lowering drug prices
Secretary of Health and Human Services Alex Azar on Thursday met with Republican lawmakers on the House Ways and Means Committee to discuss ways to lower drug prices. Azar provided lawmakers with an update on the steps the Trump administration planned to take to lower drug prices. He did not provide specifics.