July 10, 2018

NEWS
Trump Administration Takes Another Major Swipe at the Affordable Care Act. In a rare Saturday afternoon announcement, the Centers for Medicare and Medicaid Services said it will stop collecting and paying out money under the ACA's "risk adjustment" program, drawing swift protest from the health insurance industry. (Washington Post, 7/7/18)

PRESS RELEASE
FDA Announces Revised Guidance on the Testing of Donated Blood and Blood Components for Zika Virus. The revised guidance explains that, in order to comply with applicable testing regulations, blood establishments must continue to test all donated Whole Blood and blood components for Zika virus using a nucleic acid test.  (FDA, 7/6/18)

See also:  Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components (FDA, 7/18)

RESEARCH
Oral Tecovirimat for the Treatment of Smallpox. With support from NIAID, researchers from Siga Technologies investigated the efficacy of tecovirimat in nonhuman primate (monkeypox) and rabbit (rabbitpox) models in accordance with the Food and Drug Administration Animal Efficacy Rule, which was interpreted for smallpox therapeutics by an expert advisory committee.  (New England Journal of Medicine, 7/5/18)

STATEMENT
Statement from FDA Commissioner Scott Gottlieb, MD and FDA Deputy Commissioner for Foods and Veterinary Medicine Stephen Ostroff, MD, on the Ongoing Risk of Salmonella in Kratom Products. The FDA has now concluded its months-long investigation after identifying extremely high rates of salmonella contamination in kratom products collected and tested. This has led to multiple recalls, including the agency's first mandatory recall order to one supplier. In addition to the known addictive properties and serious harms linked to kratom use, the evidence from this investigation points to another significant risk with the use of kratom: salmonella. (FDA, 7/2/18)

NEWS
USDA Proposes Additional Ohio and West Virginia Counties for Oral Rabies Vaccine Trials, Supplement for the Environmental Assessment Available for Comment. USDA's Animal and Plant Health Inspection Service has prepared a supplemental environmental assessment relative to an oral rabies vaccination field trial in New Hampshire, New York, Ohio, Vermont, and West Virginia. (USDA, 7/5/18)

FUNDING OPPORTUNITY
Halting TB Transmission in HIV-Endemic and Other High-Transmission Settings. The objectives of this Funding Opportunity Announcement are to promote research to: 1) understand the critical drivers of TB transmission at the individual and population levels in high-burden settings, particularly where high incidence of HIV co-infection contributes to TB rates. 2) develop potential interventions to prevent TB transmission in HIV-endemic and other high-transmission settings and to measure the rate of transmission underpinned by an increased understanding of the biomedical basis of transmission and related risk factors. (Grants.gov, 7/3/18)

REQUEST FOR INFORMATION
NIAID Tuberculosis Strategic Plan Request for Information. In response to the US Government's alignment with the concerted global effort led by the World Health Organization (WHO) to end the tuberculosis epidemic, NIAID is developing a strategic framework to advance tuberculosis (TB) research and development for the next five years and beyond. The NIAID TB strategic framework aims to progress five areas of research opportunity vital to advancing understanding, prevention, and treatment of TB, and highlights research gaps critical to achieving the aspirational goal of ending TB. (NIH, 7/18)

COMMENTARY
Health Security Downgraded at the White House. The White House explained that its May 9 decision to dismantle the global health security directorate was intended to "streamline" operations. In reality, it was far more than that. Memories of the Ebola crisis in 2014 have faded, and the Trump administration implicitly is signaling that it flatly rejects the notion that health security ranks as a true national security policy priority.  (Center for Strategic & International Studies, 6/28/18)

NEWS
A Flu Drug May Be Poised to Upend Treatment in US. The Food and Drug Administration on Tuesday said that it would give the drug, baloxavir marboxil, a priority review, and approval has the potential to upend the way influenza is treated. (Scientific American, 6/28/18)

NEWS
National Health Care Fraud Takedown. FBI Deputy Director David Bowdich took part in a press conference today with US Attorney General Jeff Sessions, Health and Human Services Secretary Alex Azar III, and other federal officials to announce a nationwide health care fraud and opioid takedown that has resulted in charges against 601 defendants around the country, along with a total of more than $2 billion in fraud losses. (FBI, 6/28/18)

NEWS
The Military Drinking-Water Crisis the White House Tried to Hide. The Trump administration feared it would be a "public relations nightmare": a major federal study that concluded contaminated groundwater across the country, especially near military bases, was more toxic than the government realized. Political aides to President Donald Trump and Environmental Protection Agency head Scott Pruitt pressured the Agency for Toxic Substances and Disease Registry against releasing the results. (The New Republic, 6/21/18)

NEWS
The US Will Resort to DNA Tests in an Effort to Reunite Children and Their Parents. The Department of Health and Human Services said the tests are intended to speed reunifications following a court order, but they raise questions about what planning went into the separation policy. (BuzzFeed News, 7/5/18)

See also: 

• HHS Now Estimates Under 3,000 Kids Separated from Parents in Government Custody (CNN, 7/5/18)
• Democratic Lawmakers Rip HHS Secretary Call on Family Separations as "Weak" (CNN, 7/7/18)

FACT SHEET
FEMA Preparations for 2018 Hurricane Season in Puerto Rico. An emphasis on disaster planning and preparedness in Puerto Rico is expected to enhance any potential response during the 2018 hurricane season.  (FEMA, 7/6/18)

REPORT
Private Flood Insurance and the National Flood Insurance Program. The National Flood Insurance Program is the main source of primary flood insurance coverage in the United States, collecting $3.5 billion in premiums for over five million flood insurance policies. This is in contrast to the majority of other property and casualty risks, such as damage from fire or accidents, which are covered by a broad array of private insurance companies. (Congressional Research Service, 7/2/18)

NEWS
Lawmakers Ask NIH and CDC Charities for More on Donors. A key congressional spending panel has fired a shot across the bow of two federally chartered medical foundations, warning them that the way they disclose information about donors may not pass muster. It's the latest controversy involving the traditionally low-profile foundations, which over the past quarter-century have funneled nearly $2 billion to the National Institutes of Health and the Centers for Disease Control and Prevention for research, clinical trials, training, and educational programs. (Science, 7/6/18)

NEWS
FDA's Revolving Door: Companies Often Hire Agency Staffers Who Managed Their Successful Drug Reviews. Science has discovered that 11 of 16 FDA medical examiners who worked on 28 drug approvals and then left the agency for new jobs are now employed by or consult for the companies they recently regulated. This can create at least the appearance of conflicts of interest. (Science, 7/5/18)

NEWS
Data-Sharing Website May Speed Response to New Illegal Drugs. Scientists at the National Institute of Standards and Technology, the German Federal Criminal Police Office, and the US Drug Enforcement Agency have launched a website where forensic chemists can share data on new drug variants, also called drug analogs.   (NIST, 7/5/18)

See also: NPS Data Hub: A Web-Based Community Driven Analytical Data Respository for New Psychoactive Substances (Forensic Chemistry, 6/18)

WORKSHOP
NIH Workshop: Harnessing Artificial Intelligence and Machine Learning to Advance Biomedical Research. The workshop will feature leading experts from Amazon and IBM, and scientists from the NIH Clinical Center, Massachusetts Institute of Technology, Stanford University, and the University of Cincinnati who are employing AI/ML in biomedical research settings. Craig Mundie, who served on the President's Council of Advisors on Science and Technology and was formerly Microsoft's Chief Research Strategy Officer, will deliver the keynote address. (NIH, 7/2/18)

NEWS
With Bipartisan Backing, Congress Appears Likely to Increase NIH Budget Yet Again. The National Institutes of Health, in the words of director Francis Collins, is "on a roll" on Capitol Hill, with the research agency likely to receive a fourth consecutive budget increase, this year amounting to roughly $2 billion.  (STAT News, 6/26/18)

This Week's Hearings

Combating Tuberculosis in Southern Africa. US House Committee on Foreign Affairs, Subcommittee on Africa, Global Health, Global Human Rights, and International Organizations. 7/12/2018, 2 PM. Rayburn 2200. More