FDA Releases Plan to Improve Biosimilar Approval Times
From ACG FDA Related Matters Committee Chair Stephen Hanauer, MD, FACG
This past Thursday, the U.S. Food and Drug Administration (FDA) proposed improving the process for biosimilar applications seeking to expand the indicated use of their products for different health conditions. Although ACG members can prescribe biosimilars off-label like any other drug product, the guidance is the first to deal with the issue of “skinny labels,” in which a biosimilar seeks licensure for some but not all of the uses licensed for the reference drug.
The guidance document outlines a plan to shorten the FDA's expanded use application reviews to 6 months (from 10 months), as part of the Trump Administration's effort to get more generics approved and lower health care prices. It also clarifies that the biosimilar maker can avoid patent infringement risks by asking the FDA to delay considering a specific use for the drug until patents or exclusivity periods expire.
According to Politico, about a third of the 26 licensed biosimilars are on the U.S. market, mostly due to legal challenges such as unanticipated issues associated with the reference drug’s patents.
FDA and FTC Announce New Efforts to Further Deter Anti-Competitive Business Practices
On Monday, the FDA and the Federal Trade Commission signed a joint statement describing key steps the agencies will take to address false or misleading promotion about biosimilars and deter anti-competitive behavior.
President Trump's State of the Union: Healthcare Priorities
From ACG Legislative and Public Policy Council Chair, Whitfield L. Knapple, MD, FACG
On Tuesday evening, President Trump delivered his State of the Union address, continuing an annual tradition started in 1934 to formalize a report to Congress by the nation’s chief executive. While his speech covered many topics, President Trump mentioned health policy issues, including guaranteeing coverage for patients with pre-existing conditions, protecting Medicare, and pledged to sign legislation to help lower prescription drug prices. He also expressed support for the Advancing Support for Working Families Act, extending family leave.
President Trump is expected to submit his annual budget to Congress for Fiscal Year 2021 in the coming days. ACG will review these proposals and the potential impact to clinical GI.
New Practice Management Toolbox E-Book!
The ACG Practice Management Committee is proud to announce a digital compendium of articles in the Practice Management Toolbox series as well as "Law Mind" articles published in ACG MAGAZINE.
The Practice Management Committee is confident this series and the e-Book compendium will provide a valuable resource for members striving to optimize their practices.
Professional Service Agreements: Perfect Solutions to Affiliations? By Ann Bittinger, Esq.
ACG recently commissioned Ann Bittinger, Esq. to draft a white paper on Professional Services Agreements (PSA) as a resource for our members. In addition to guidance and perspective, Ms. Bittinger also provides template legal contract language that will be helpful to ACG members negotiating a PSA with a health system. Download this language for your use!
What is the Practice Management Toolbox?
Gastroenterologists in private practice find themselves working in a time of unprecedented transformation. Pressures are high as they make important management decisions that profoundly affect their business future, their private lives, and their ability to provide care to patients. The ACG Practice Management Committee has a mission to bring practicing colleagues together to explore solutions to overcome management challenges, to improve operations, enhance productivity, and support physician leadership. It was in this spirit that the Practice Management Toolbox was created.
The Toolbox is a series of short articles, written by practicing gastroenterologists, that provide members with easily accessible information to improve their practices. Each article covers an issue important to gastroenterologists and physician-lead clinical practices. They include a brief introduction, a topic overview, specific suggestions, helpful examples and a list of resources or references. Each month a new edition of the Toolbox will be released and will then remain available here along with all previous editions. The Practice Management Committee is confident this series will a provide valuable resource for members striving to optimize their practices.