PBM transparency bill introduced

While we wait to see what happens with government funding before tomorrow’s deadline, we have news on a new PBM transparency bill, a new collaboration to help patients enroll in clinical trials, and a win for patients with Pompe disease. (590 words, 2 minutes, 57 seconds)

PBM transparency bill introduced in Senate

A bill designed to prevent pharmacy benefit managers (PBMs) from using their market power to drive up drug prices was introduced in the Senate yesterday.

The bill: The Modernizing and Ensuring PBM Accountability (MEPA) Act, introduced by Senate Finance Committee Chair Ron Wyden (D-OR) and Ranking Member Mike Crapo (R-I), is designed to make PBM practices more transparent and to increase competition in the pharmaceutical supply chain.

What PBMs do: Choose which drugs receive insurance coverage, charging drug makers rebates and fees for covering them. PBMs profit from keeping drug prices high—and are often integrated with pharmacy chains and insurers, with three PBMs controlling 80% of the market.

What the bill would do: Prevent PBMs from taking Medicare compensation based on “sticker prices,” establish independent audit and enforcement measures to increase transparency, and give relief to independent pharmacies, which face uncompetitive pressure from PBMs.

BIO launches survey to improve FDA communications

BIO launched a survey of biotech companies about interactions with the Food and Drug Administration (FDA) to help improve communications between drug sponsors and the regulator.

What: BIO’s “FDA Communications Survey” is designed to obtain companies’ experiences, challenges, and lessons learned in order to provide recommendations for better communications between the FDA and biotech firms.

Who: All biotech companies that have engaged with the FDA during the drug development process are invited to provide their feedback.

Why it matters: “One of the most common remarks we hear from companies seeking FDA approval is that they need input and feedback from FDA that is both timely and reliable,” says Rachael Anatol, BIO’s SVP, Science and Regulatory Affairs. This survey is designed to address these communication challenges.

How can I take part? BIO members who did not receive an email about how to participate in the survey are encouraged to contact fdasurveysupport@bio.org.

TrueTrials helps patients enroll in clinical trials with FDA oversight

A collaboration between the Food and Drug Administration (FDA) and researchers is helping people who seek cutting-edge cures find clinical trials.

Introducing TrueTrials: With a focus on regenerative medicine and cell therapy, TrueTrials helps patients and their families who want to enroll in clinical trials that offer the guarantee of safety provided by FDA oversight.

Why it matters: It is difficult for patients to navigate the massive list of trials at clinicaltrials.gov. TrueTrials aims at “democratization of access to cell therapy trials” by making it easier for everyone to find trials meeting FDA standards.

Another benefit: TrueTrials also helps researchers running cell therapy clinical trials to recruit participants.

Read more in Bio.News.

More Health News: 

Amicus Therapeutics: Amicus Therapeutics announces FDA approval and launch of new treatment for Pompe disease
“Today’s FDA approval of Pombiliti and Opfolda is a testament to the power of science, medicine, and our passionate determination to improve the lives of people living with Pompe disease. This approval embodies our Amicus spirit, passion, and resilience and is a very meaningful step for the Pompe community,” said John F. Crowley, Executive Chairman of Amicus Therapeutics.

Bio.News: Battling sepsis and superbugs requires awareness and policy
“Our primary weapon in the battle against sepsis is antimicrobials, such as antibiotics. But these drugs are losing their effectiveness as superbugs develop antimicrobial resistance (AMR), which poses both medical and public health challenges. Battling AMR therefore requires use of another important weapon: public awareness. Awareness is the driver behind Sepsis Alliance marking Sepsis Awareness Month every September since 2011.”

President Biden’s Friday: A trip to Arlington with VP Harris.

What’s Happening on Capitol Hill: Government funding, the Farm Bill, the Pandemic All-Hazards Preparedness Act ,and the Animal Drug User Fee Act all expire tomorrow. We’ll be watching for their eventual passage.