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The Pulse of the Pharmaceutical Industry

U.S. House panel spotlights use of FDA rules to slow generic drugs

Written by: | | Dated: Thursday, July 27th, 2017


WASHINGTON (Reuters) — Republican and Democratic lawmakers on Thursday discussed ways to prevent drugmakers from using rules developed to safeguard patients to instead block the sale of cheaper medicines.

The focus at a hearing, held by members of the House Judiciary Committee’s antitrust subcommittee, was on the use by some brand name drug companies of a Food and Drug Administration program, called “Risk Evaluation and Mitigation Strategies” or REMS, to protect their pharmaceuticals from generic competition.

Under the FDA program, generic companies often must buy samples of a drug they want to copy from the brand name company that makes the drug, rather than a wholesaler.

Drugmakers have been accused of refusing to make such sales, and the House and Senate are both considering legislation that would allow generic drug companies to sue to demand samples.

The legislation under consideration would also provide for damages for generic companies denied access to brand name drugs.

Lawmakers from both parties expressed discomfort with the practice of blocking cheaper drugs from getting to market. Representative John Conyers, the Judiciary Committee’s top Democrat, asked how he could help to stop it.

High and rising drug prices have proved a pain point for many voters, particularly those without insurance or on tight budgets. Drug companies argue that they need the high prices to fund multibillion-dollar research to discover the next life-saving medicine.

Republican Bob Goodlatte, the Judiciary Committee’s chairman, noted voter concerns about the high price of some medicines.

“While it is imperative that the U.S. continue to remain the world leader and innovator in the pharmaceutical market, it is important that … antitrust concerns be given significant deliberation,” he said.

Scott Gottlieb, an FDA commissioner, testified that drug companies sometimes “game” the government system.

Markus Meier, acting head of competition for the Federal Trade Commission, said any delay in the rollout of generic drugs has clear consequences.

“When drug companies can succeed in delaying generic entry, American consumers will pay higher prices for prescription drugs,” he said.

Under the FDA’s REMS program, 71 drugs are covered by varying levels of protection. In some of the most strict cases, the drugs can only be given to a patient on a registry or dispensed in a particular healthcare setting, like a clinic.

Drugs with REMS include Indivior’s Suboxone, Sanofi Genzyme’s Lemtrada and Danco Laboratories’ Mifeprex.


Reporting by Diane Bartz; Editing by Tom Brown


Reuters source:


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