Hart Health Strategies provides a comprehensive policy briefing on a weekly basis. This in-depth health policy briefing is sent out at the beginning of each week. The health policy briefing recaps the previous week and previews the week ahead. It alerts clients to upcoming congressional hearings, newly introduced bills, regulatory announcements, and implementation activity related to the Patient Protection and Affordable Care Act (PPACA) and other health laws.


Stakeholders Pledge to Increase Responsible Antibiotic Use

The White House placed a spotlight on the issue of bacteria that is resistant to antibiotics last week, holding a summit that was attended by 150 stakeholders, including representatives of the agricultural industry, pharmaceutical industry, medical device industry, food producing and processing industry, hospitals, research firms, consumer advocacy groups, professional medical societies, restaurant chains and the retail industry. Attendees discussed the prevention of antibiotic overuse in both humans and animals, which worsens the rise of deadly drug-resistant bacteria. During the summit, the Administration announced several measures to fight antibiotic resistance and increase the responsible use of antibiotics. Following an executive order signed by the President, the General Services Administration (GSA) will begin prioritizing the option of antibiotic free meat and poultry in federal cafeterias. The President also noted that the Presidential Food Service would begin serving food that has been raised under responsible antibiotic practices. The Food and Drug Administration (FDA) announced the finalization of a regulation that would bring the use of farm antibiotics under a veterinarian’s supervision, so as to scale back the practice of using antibiotics to make animals grow, rather than to treat infections. The rule details what veterinarians must do when authorizing the use of antibiotics in livestock, and goes into full effect in December 2016. Farmers will be required to get a prescription for the therapeutic use of antibiotics which are also medically important to humans. The rule prohibits the use of antibiotics for any purposes other than the treatment of sick animals, and promotes the judicious use of medically important antibiotics in animal feed. Discussions were held on efforts to develop rapid diagnostics to ensure that the right drug is provided to the right patient, in order to prevent over treatment or treatment with an inappropriate antibiotic, which further contributes to resistance. Hospital systems discussed actions underway to improve antibiotic prescribing practices. U.S. Department of Health and Human Services (HHS) Secretary Sylvia Mathews Burwell announced that HHS will develop a rule outlining the antibiotic stewardship programs which hospitals must implement, and will award a $20 million prize for the development of a rapid, point of care diagnostic test to track the spread of bacteria resistant to medicine. During the summit many stakeholders committed to making changes to slow the emergence of resistant bacteria and prevent the spread of resistant infections. A list of formal commitments made by private sector leaders to improve antibiotic use and prescribing can be found here. The forum is the Administration’s latest attempt to tackle the rise of antibiotic resistance and curb the use of antibiotics in meat and poultry. The event follows the release of
a national action plan for combating antibiotic resistant bacteria in March of this year. Also last week, Rep. John Shimkus (R-Ill.) and Rep. Gene Green (D-Texas) introduced the Antibiotic Development to Advance Patient Treatment (ADAPT) Act, to speed the approval of new antibiotics. The legislation would allow the approval of antibiotics for life-threatening diseases based on smaller clinical trials. H.R. 2629 calls on the Centers for Disease Control and Prevention (CDC) to boost surveillance efforts and to make their data public. Antibiotic resistance causes at least two million illnesses and 23,000 deaths in the United States annually, according to the CDC. The ADAPT Act is included in H.R. 6, the 21st Century Cures Act which is expected to be considered on the House floor the week of June 15th.

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