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ASCRS Joins the Alliance of Specialty Medicine in a Letter to Congress Expressing Concern on Provisions in STAR Act to Require Manufacturers to Report Drug and Device Samples Distributed to Physicians

Recently, ASCRS joined the Alliance of Specialty Medicine in a letter expressing concerns on provisions in H.R. 2113, the “Prescription Drug Sunshine, Transparency, Accountability, and Reporting (STAR) Act of 2019,” that may impact patient access to samples of drugs and devices. The STAR Act would require manufacturers to report, in addition to other sunshine reporting requirements, the value of samples they provided to physicians during the reporting period. We expressed concerned that companies may become unwilling to provide samples due to reporting burdens, and as a result, patients’ may not have access to sample treatments from their physicians. This is particularly problematic for physicians who sometimes rely on these samples to begin treatment.

In response to our letter, we received a meeting request from Rep. Michael Burgess, MD (R-TX), who is Ranking Member of the House Energy and Commerce (E&C) Health Subcommittee, and Rep. Larry Bucshon (R-IN) to discuss the issue in more detail. We will keep you updated.

 

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