June 2012 AMA Advocacy Update: Senate Approves FDA Safety and Innovation Act, AMA Provides Recommendations for Alternative Payment Models June 4, 2012 Advocacy, AMA HR 4095, S 2002, S 3187, SGR, AMA Advocacy Update 0 Excerpts from the June 2012 AMA Advocacy Update. For a pdf copy of the full report, click here. To view the most current national advocacy update, click here. Senate Approves Food and Drug Administration Safety and Innovation Act AMA Works to Improve Provisions to Address Rogue Online Pharmacies AMA Provides Information to Ways and Means Committee on Quality Improvement and Alternative Payment Models Senate Approves Food and Drug Administration Safety and Innovation Act On May 24, the Senate passed S 3187, “The Food & Drug Administration Safety and Innovation Act,” by a vote of 96-1. The legislation would reauthorize the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA), and newly authorize user fees for generic drugs and biosimilars. It also includes provisions to address drug shortages and incentivize the development of new antibiotics. S 3187 was greatly improved from the original draft, and reflects a number of AMA’s requested changes. For example, the AMA urged the Health, Education, Labor and Pensions (HELP) Committee to expand manufacturers’ early notification requirement to report expected shortages for all drugs and to modify provisions relating to new antibiotic development. On May 30, the House passed its version of the user fee reauthorization legislation, HR 5651, by a vote of 387-5. Although the bills are similar minor difference will be worked out in conference committee. The user fees are set to expire on September 30, final Congressional action is expected by June 30. AMA position: The AMA strongly supports the passage of legislation to address drug shortages and properly incentivize new antibiotic development as a part of the FDA User Fee reauthorization bill. The AMA sent a letter to the HELP Committee commending the improved language and will continue to advocate for its priorities as the bills are reconciled in a House-Senate conference. AMA Works to Improve Provisions to Address Rogue Online Pharmacies The AMA has been engaged in reviewing and commenting on several recent drafts of the “Online Pharmacy Safety Act,” originally introduced by Sen. Diane Feinstein (D-Calif.) and Rep. Bill Cassidy, MD (R-La.) as S 2002 and HR 4095, respectively. Rogue online pharmacies represent a serious and growing threat to the health and safety of patients. The legislation as originally introduced would address this by establishing a Food and Drug Administration administered registry to identify legitimate and safe online pharmacies, an approach supported by the AMA. Several attempts have been made to amend the legislation so that it could be included in the user fee reauthorization legislation. Unfortunately, the registry provisions were removed from subsequent versions of the legislation and the bill was expanded beyond its original intent. Recent drafts of the bill would only retain provisions that would set a federal standard for a valid prescription. This would undermine state valid prescription standards which are also intertwined with other areas of their medical practice codes such as licensure, telehealth and patient safety. The AMA has expressed its concerns over this federal intervention with the proper state regulation of the practice of medicine to the sponsors of the bill and the HELP and Energy and Commerce Committees. The Senate-passed version of the user fee reauthorization legislation (S. 3187) contains a GAO study on rogue online pharmacies. At this writing, the House bill does not include any similar provision. AMA position: The AMA believes that current versions of this bill constitute an unwarranted and inappropriate federal intrusion into states’ ability to regulate the practice of medicine. The AMA is committed to working with the sponsors to enact laws that will effectively reign in rogue online pharmacies while at the same time protecting the ability of states to regulate the practice of medicine. AMA Provides Information to Ways and Means Committee on Quality Improvement and Alternative Payment Models On April 27, 2012, the House Committee on Ways and Means wrote to more than 70 physician organizations requesting information on quality and efficiency improvements, alternative payment models, patient involvement and regulatory relief as part of their efforts to find a long term replacement for the sustainable growth rate (SGR) formula. In response, the AMA has submitted a 26-page letter answering specific questions put forth by the committee. Specifically, the AMA outlined strategies that the physician community could support to both reduce the growth in costs and improve patient outcomes, including a broad rage of payment reform options. AMA also outlined the extensive activities of the Physician Consortium for Performance Improvement and other activities that are already underway, as well as regulatory relief that is needed in order for new payment methodologies to succeed. View the complete letter. The AMA will continue to work with Congress in their ongoing efforts to find a replacement for the failed SGR formula. Comments are closed.
