D.C. Week: FDA Proposes New Blood Donation Rules for Gay Men
FDA lifts ban for men who have sex with men, with caveat.
WASHINGTON -- The FDA issued proposed rules to lift the ban on blood donation by men who have sex with men, and the Obama administration clarified rules for birth control coverage as the weather warmed up here in the nation's capital.
FDA Proposes Lifting Ban on MSM Blood Donation
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The FDA on Tuesday issued draft guidanceproposing to lift the agency's ban on blood donations from men who have sex with men, as long as the donors have abstained for a year.
"Male donors previously deferred because of a history of sex with another man, even one time, since 1977, may be eligible to donate provided that they have not had sex with another man during the past 12 months and they meet all other donor eligibility criteria," the FDA wrote in its "Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products."
In addition, "Male donors [previously] deferred because of a history of sex with another man in the past 12 months may be eligible to donate provided they have not had sex with another man during the [immediate] past 12 months and they meet all other donor eligibility criteria," the guidance stated.
The American Medical Association praised the proposed guidance. "The AMA commends the FDA for taking a step in the right direction to end the lifetime ban that prohibits men who have had sex with men (MSM) from ever donating blood," AMA PresidentRobert Wah, MD, said in a statement.
However, other groups were less enthusiastic. "This policy prevents men from donating life-saving blood based solely on their sexual orientation rather than actual risk to the blood supply," David Stacy, director of government affairs at the Human Rights Campaign, an organization that works for equal rights for lesbian, gay, bisexual, and transgender individuals, said in a blog post. "It simply cannot be justified in light of current scientific research and updated blood screening technology."
Obama Administration Clarifies Birth Control Mandate
Health insurers must cover without cost-sharing all 18 forms of contraception listed in the FDA's birth control guide, the Obama administration said in guidance issued Monday.
"The FDA currently identifies 18 distinct methods of contraception for women, and the ... guidelines are designed to provide women's access to the full range of these contraceptive methods identified by the FDA, as prescribed by a healthcare provider," stated a fact sheet on the guidance, which was issued jointly by the departments of Labor, Treasury, and Health and Human Services. "Thus, plans and issuers must cover without cost sharing at least one form of contraception within each method the FDA has identified."
For example, the fact sheet continued, "For the hormonal contraceptive methods, coverage must include (but is not limited to) all three oral contraceptive methods (combined, progestin-only, and extended/continuous use), injectables, implants, the vaginal contraceptive ring, the contraceptive patch, emergency contraception (Plan B/Plan B One Step/Next Choice), emergency contraception (Ella), and IUDs with progestin. Accordingly, a plan or issuer may not impose cost-sharing on the ring or the patch."
FDA: Smokeless Tobacco Warning Stays
The FDA on Monday denied a petition by two tobacco companies to ease up on the warnings around smokeless tobacco.
R.J. Reynolds and the American Snuff Company had requested that the FDA change one of the four warning statements required for product packages and advertising from "This product is not a safe alternative to cigarettes" to "No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes."
A supplement to the petition suggested "No tobacco product is safe; however, exclusive use of smokeless tobacco products presents substantially less risk to health than cigarettes" as an alternative.
The FDA's response indicated neither change would be made.
Regardless of whether people might read the current label as saying smokeless tobacco isn't a safer alternative, it is factual as written because no tobacco product is safe, the agency argued.
137 Million Can Access Free Preventive Services, HHS Says
About 137 million people with private health insurance now have access to free preventive services as a result of the Affordable Care Act (ACA), the Department of Health and Human Services (HHS) announced Monday.
The ACA requires that insurers offer certain preventive services without costs, including contraception (see story above), obesity screening and counseling, breastfeeding support and supplies, HIV screening, and vaccinations to prevent flu and other diseases. The 137 million who have access to the free services include 15 million blacks, 17 million Latinos, and 8 million Asian-Americans, HHS noted.
"These services can substantially improve the health of families, and in some cases even save lives," HHS Secretary Sylvia Burwell said in a statement. "This can make a tremendous difference in the health of Americans."
Next Week
On Wednesday, the Senate Special Committee on Aging will hold a hearing on "Challenging the Status Quo: Solutions to the Hospital Observation Stay Crisis."
Also on Wednesday, the Alliance for Health Reform will hold a briefing on "Biosimilars in the U.S.: Current and Emerging Issues."
On Thursday, the House Subcommittee on Oversight and Investigations will hold a hearing entitled "What are the State Governments Doing to Combat the Opioid Abuse Epidemic?"
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