Regulatory and Washington

SILVER SPRING, Md. — The Food and Drug Administration on Thursday allowed 23andMe to market its Personal Genome Service Genetic Health Risk tests for 10 diseases or conditions directly to consumers. The allowance makes 23andMe’s GHR the first direct-to-consumer test authorized that provides information about a patient’s genetic predisposition to diseases or medical conditions.

This week, the Senate Judiciary Committee considered the nomination of Judge Neil Gorsuch to the United States Supreme Court. Since vacancies on the bench are rare and the political stakes so high, few spectacles in Washington D.C. invite this level of drama. He was confirmed by the committee but when his nomination eventually goes to the floor of the Senate for a vote, the real fun will begin. (See “nuclear option.”) Lost in the hype is what his eventual seat on the court will mean to retail operators.

WASHINGTON — Retailers may soon have a voice when it comes to disclosing surcharges related to card payments.

The Supreme Court ruled on Wednesday, March 29, that First Amendment free speech rights should be considered when determining how merchants disclose to their shoppers that credit card swipe fees can drive up the price of merchandise.

WASHINGTON — The Natural Products Association last week hosted its members from across the nation for its 20th Annual Natural Products Day in the nation's capital.  NPD attendees, which included retailers, suppliers, distributors and other industry consultant members, met with more than 100 members of Congress and staff to educate them on the industry’s issues and natural products’ roles in preventive health care and overall wellness.

ALEXANDRIA, Va. — All told, as many as 118 healthcare organizations have signed letters supporting legislation that would prohibit retroactive pharmacy direct and indirect remuneration (DIR) fees in the Medicare Part D program.

The support is up significantly from last year, when more than 95 health care organizations signaled their support in similar letters to the House and Senate last September.

OLYMPIA, Wash. — The retail pharmacy industry is pursuing legal action against Washington state over a “substantively and procedurally flawed” rule  that would pay pharmacies below the actual cost to dispense Medicaid prescriptions.

The National Association of Chain Drug Stores joined the Washington State Pharmacy Association and the National Community Pharmacists Association in preventing a rule that would jeopardize patient access to their medications, the associations said.

LITTLE ROCK, Ark. — As it builds a framework for Arkansas' forthcoming medical marijuana program — which voters approved as an amendment to the state constitution in November — the Arkansas House of Representatives on Tuesday evening took a step forward in involving the state’s pharmacists in the medical marijuana program. The House passed a bill requiring pharmacist consultation for dispensaries, sending it to the Arkansas Senate, where it made its way out of committee Wednesday for a Thursday vote with the recommendation that it pass.  

WASHINGTON — President Donald Trump’s choice to lead the Food and Drug Administration hopes to lower drug costs by approving cheaper generic drugs more quickly.

According to Bloomberg, former FDA Deputy Commissioner Scott Gottlieb would make streamlining drug approvals his top priority, with a particular focus on complex medications that combine old drugs with newer delivery devices, as well as ones with unusually complicated formulations. The news outlet added such changes in approach could come without Congressional approval.