House advances bills to boost small biotechs

A busy day on Capitol Hill advanced several BIO-backed bills that would help small biotechs, plus hearings that covered topics including PBMs, price controls, and 340B. (594 words, 2 minutes, 58 seconds)

House committee advances bills that would give small biotechs a boost

A host of BIO-supported legislation was approved in yesterday’s House Financial Services Committee markup of 15 bills designed to relieve regulatory burdens and facilitate access to capital.

How we got here: The JOBS Act of 2012 enabled a wave of public market access for small biotechs, and BIO supports improvements to increase access.

A few bills approved by the committee yesterday include:

• The Equal Opportunity for All Investors Act, which would create a certification exam to qualify as an accredited investor so more qualified investors can participate at these critical early stages.
• The Small Entity Update Act, which ensure regulators appropriately classify small entities so they can receive JOBS Act support.
• The Expanding Access to Capital Act, which would extend the emerging growth company exemption period of the JOBS Act by another five years.

What’s next: BIO will work with Congress and regulators to adopt rules to protect investors and preserve market integrity while facilitating robust capital formation. 

Read more details at Bio.News.

Capitol Hill update: PBMs, drug pricing, FDA approval, 340B

A pair of House hearings yesterday covered key priorities for BIO—here are the highlights.

The hearings: The House Energy & Commerce Health Subcommittee held a hearing on “transparency and competition in health care,” and the House Ways & Means Oversight Subcommittee held a hearing on “tax-exempt hospitals” and 340B.

PBMs: E&C Health Subcommittee Chair Brett Guthrie (R-KY) promoted bipartisan legislation to prevent PBMs from inflating prices for a profit—including his Pharmacy Benefits Manager Accountability Act, co-sponsored with Reps. Ann Kuster (D-NH), Anna Eshoo (D-CA), and Buddy Carter (R-GA).

More Reading: PBM roundup: Top 6 Actions to Watch 

Drug price controls: E&C members questioned Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure about price controls. “How is CMS going to make sure that the U.S. leads the world in getting these life-saving cures?” asked Rep. Bob Latta (R-OH).

Accelerated Approval should be sufficient for CMS coverage, said Reps. Nanette Barragan (D-CA), Larry Bucshon (R-IN), and Eshoo, who criticized how CMS has handled breakthrough Alzheimer’s drugs and asked CMS to adhere to the FDA’s and VA’s gold standard when it comes to the expected approval of LEQEMBI.

340B: The 340B program to provide discount drugs to marginalized communities is a “black box” abused by hospitals, Johns Hopkins’ Ge Bai told the Ways & Means Oversight Subcommittee. Simple changes, like requiring hospitals to disclose property tax rates and 340B profits, could create transparency.

What’s next: BIO is watching legislative developments related to PBMs and the 340B program—stay tuned.

More Health News: 

Seres Therapeutics: Seres receives FDA approval for oral microbiome therapeutic
“Since being founded by Flagship Pioneering over a decade ago, Seres has led the development of microbiome therapeutics, and today’s FDA approval of VOWST as the first orally administered microbiota-based therapeutic for the prevention of recurrent C. difficile infection marks a tremendous milestone for the patient community, and for Seres,” said Seres President and CEO Eric Shaff.

President Biden’s Thursday: Greeting staff and their kids on the White House lawn for Bring a Kid to Work Day.

What’s Happening on Capitol Hill: A House Judiciary Courts, Intellectual Property, and the Internet Subcommittee will hold a general oversight hearing on the U.S. Patent and Trademark Office (USPTO). The Federal Trade Commission (FTC) investigation of PBMs may come up in a House Appropriations Financial Services and General Government Subcommittee hearing on the FTC’s budget. The House Energy and Commerce Oversight and Investigations Subcommittee hearing on Biosafety and Risky Research: Examining if Science is Outpacing Policy and Safety” promises to look at “potential pandemic pathogens, current biosafety practices at high-containment laboratories.”