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January 2017
POLICY NEWS
Your Voice in Washington

IDSA continues bringing issues of concern to the infectious diseases community to the attention of policymakers in Washington, DC:

Antimicrobial Drug Shortages: IDSA is alerting Congress about persistent antimicrobial drug shortages and their impact on patient care, including results from a 2016 Emerging Infections Network survey, in which 73 percent of respondents reported that a drug shortage had affected patient outcomes. "As the threat of antimicrobial resistance grows, the revelation that almost four of five physicians surveyed had to use a broader spectrum drug due to drug shortages is particularly disturbing," wrote IDSA President William G. Powderly, MD, FIDSA. IDSA will continue urging Congress to take additional steps to prevent and address drug shortages.

Role of ID in Stewardship: Dr. Powderly also gave a presentation to the Presidential Advisory Council on Combating Antibiotic Resistant Bacteria earlier this month on ID physician workforce issues and the value ID physicians bring to infection prevention and antimicrobial stewardship.

Common Rule for Protecting Human Subjects of Research: In its final days, the Obama administration released a final revised Federal Policy for the Protection of Human Subjects (Common Rule). IDSA and sister societies commented repeatedly on proposed revisions, emphasizing the need to allow researchers access to biospecimens. While IDSA is still reviewing the final rule, it does include key IDSA recommendations: (1) does not subject research on nonidentified biospecimens to the Common Rule; (2) allows the use of broad consent for storage, maintenance and secondary research of identifiable private information and biospecimens; and (3) does not adopt new privacy safeguards for identifiable private information and biospecimens.

Quarantine Rule: The Centers for Disease Control and Prevention (CDC) finalized its quarantine rule earlier this month, incorporating recommendations from IDSA. The new rule: (1) clarifies that quarantine protocols for individual outbreaks will change based upon most current scientifically verified epidemiological evidence; (2) requires CDC to provide accommodations, communication capabilities and medical care to quarantined individuals; and (3) states that federal quarantine orders shall be reassessed no later than 72 hours after issuance.

Laboratory Developed Tests (LDTs): The Food and Drug Administration (FDA) has issued a discussion paper on the proposed regulation of LDTs. The paper's goal is to further public discourse on LDTs; it is not enforceable, is not an official agency position, and it's unknown whether it reflects the new administration's thinking. IDSA had previously expressed concerns about the impact of new regulations on lab tests that ID physicians rely upon to guide treatment decisions (see IDSA's position statement in CID). While the discussion paper's approach would expand FDA regulation of LDTs, it differed in important ways from the initial FDA proposal. For example, the discussion paper proposed: 1) "grandfathering," or exempting from regulation, most existing LDTs; 2) expediting the premarket review process for LDTs by leveraging accepted reference and review standards for analytical validity and permitting clinical validity to be established by sources (such as literature and well-curated databases) that meet the valid scientific evidence standard; and 3) speeding up the phase in of FDA regulation over four years instead of nine. IDSA is reviewing the discussion paper and preparing a comprehensive response.

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