Regulatory and Washington

SILVER SPRING, Md. — Food and Drug Administration commissioner Margaret Hamburg on Wednesday issued a public statement that the agency was prepared to approve Plan B as a nonprescription medication, but reversed that decision following a directive from the Department of Health and Human Services Wednesday morning.

SILVER SPRING, Md. — Prescribers, patients and specialty care centers no longer will be required to enroll in safety monitoring programs for two drugs used to treat low platelet counts, following changes to their risk evaluation and mitigation strategies.

WASHINGTON — The Department of Health and Human Services on Wednesday denied a request made by Teva Pharmaceuticals to relax merchandising restrictions for the emergency contraceptive Plan B. Presently, Plan B can be sold without a prescription to women older than 17 years old but only in a pharmacy and from behind the pharmacy counter. Women younger than 17 years require a prescription to acquire Plan B.

WASHINGTON — The Food and Drug Administration will decide on Wednesday whether to remove merchandising restrictions on the emergency contraceptive Plan B and allow the product to be merchandised in the front-end without age restrictions, according to a report published Monday in the Washington Post.

SILVER SPRING, Md. — The Food and Drug Administration and the Federal Trade Commission on Tuesday issued seven warning letters to companies marketing over-the counter human chorionic gonadotropin products that are labeled as "homeopathic" for weight loss. The letters warn the companies that they are violating federal law by selling drugs that have not been approved and by making unsupported claims for the substances. There are no FDA-approved HCG drug products for weight loss.

WASHINGTON — George Paz, Express Scripts chairman and CEO, and David Snow, Medco Health Solutions chairman and CEO, were in a pair of hot seats Tuesday afternoon before the Senate Committee on the Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights. Many of the questions posed by Senators on the subcommittee challenged the respective chief executives on how the proposed merger would negatively impact retail pharmacy and how the proposed merger would result in a dominant marketshare of the mail order pharmacy business.

WASHINGTON — The Federal Trade Commission last week jointly filed a complaint with the U.S. Attorney's Office for the District of Connecticut, seeking to permanently stop a Connecticut-based operation that allegedly used fake news websites to promote its products, made deceptive weight-loss claims and told consumers they could receive free trials of acai berry and "colon cleanse" products, only if they paid the nominal cost of shipping and handling.

Bootlegging, debauching and murdering its way through the second season, HBO’s Prohibition-themed series “Boardwalk Empire” has dramatized an era alien to its viewers but whose vestiges have remained in much of the country.