Pharmaceutical News
Drug price disclosure rule by Department of Health and Human Services rule blocked by Federal Judge
2019/07/12

U.S. District Judge Amit Mehta has ruled that the Trump Administration does not have the regulatory power to make drug manufacturers include the cost of drugs in TV commercials.

Merck & Co, Eli Lilly & Co and Amgen Inc have contested the TV commercial rule on grounds that the Department of Health and Human Services (HHS) cannot do more than what the U.S. Congress has authorized and cannot force them to disclose drug prices. The company said that in the absence of legal approval by the government, they would not comply with the rule that would have come into effect today.

Drug companies could be shamed into lowering their prices if drug prices are revealed in TV commercials as a way to help address runaway drug prices in the U.S., HHS Secretary Alex Azar was quoted as saying in a Reuters report when the bill was announced on May 8 this year.

The bill was first proposed in May 2018, as part of U.S. President Donald Trump’s blueprint to cut drug prices.

Judge Mehta said that while the policy could be an effective tool, no matter how vexing the problem of spiraling drug costs may be, the HHS cannot do more than what Congress has authorized.

Many pharmaceutical companies have opposed the rule. The Pharmaceutical Research and Manufacturers of America, the biggest lobbying group in the U.S., said that listing the suggested retail price could confuse some patients and deter them from seeking treatment.

Merck & Co, Eli Lilly & Co and the Association of National Advertisers on June 14 jointly sued the Trump Administration, arguing that forced disclosure of drug prices, which has nothing to do with health care insurance beneficiaries, would cause confusion among consumers.

Drug makers have said that the suggested retail prices do not reflect the true cost of drugs, as it does not include discounts and rebates negotiated by pharmacy benefit managers.

The new rule stipulated that for any drug with a price higher than US$35 and with treatment periods longer than one month, drug makers would have to disclose their price. According to the HHS, the 10 most advertised drugs are priced between US$488 and US$16,938 for each month of treatment.

【2019-07-09 / CNA】