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Morning Briefing

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Wednesday, Jul 17 2019

Full Issue

Perspectives: A One-Size-Fits-All Approach Isn't Going To Be The Answer For The Country's Drug Pricing Problem

Read recent commentaries about drug-cost issues.

A majority of Americans prefer greater regulation of prescription drug prices, meaning government intervention to lower them.But don鈥檛 count on a single policy to address a nuanced problem. 鈥淎ll low-priced drugs are alike; all high-priced drugs are high priced in their own way,鈥 Craig Garthwaite, a health economist from Northwestern University鈥檚 Kellogg School of Management, wrote with a colleague. (Austin Frakt, 7/15)

Last week was supposed to be a turning point for drug price transparency. The Department of Health and Human Services planned to implement a new rule requiring drug commercials on television to disclose the 鈥渓ist price鈥 of the medication being advertised. According to the HHS press release, this would be the most significant single step any administration has ever taken with regard to drug pricing. But it isn鈥檛 going to happen. Three big drug companies, Merck, Eli Lilly and Amgen along with an industry trade group, the Assn. of National Advertisers, filed a successful lawsuit blocking the rule. According to Judge Amit P. Mehta of the United States District Court in the District of Columbia, HHS does not have the authority to mandate price disclosure. (Steven Woloshin, 7/16)

The safety of the supply chain for pharmaceuticals in the United States must be built with solid links. That hasn鈥檛 always been the case, which is why the Drug Quality and Security Act (DQSA) was signed into law in 2013. Part of that law (Title II) mandates the development of a national 鈥渢rack-and-trace鈥 electronic system that documents a drug鈥檚 distribution path from the manufacturing plant to the pharmacy counter. It facilitates detection and removal of potentially dangerous drugs from the drug supply chain. This system, which will be fully implemented in the next few years, will extend to drugs manufactured outside in the U.S. in FDA-registered facilities. (Jane Horvath, 7/16)

Over the past 30 years, a lot of drug manufacturing has been offshored. With generics comprising 90 percent of the medicines Americans consume, there鈥檚 now a growing reliance on China for essential drugs. The U.S. no longer makes penicillin, for example, with the last U.S. penicillin plant closing in 2004.Now, the U.S. has virtually no capacity to make generic antibiotics used to treat ear infections, strep throat, pneumonia, urinary tract infections, sexually transmitted diseases, Lyme disease聽and other illnesses.聽And when the U.S. government needed to buy 20 million doses of the antibiotic doxycycline after the 2001 anthrax attacks, it turned to a European supplier that sourced its ingredients from China. (Rosemary Gibson, 7/14)

Three states 鈥 Vermont, Florida, and Colorado 鈥 recently passed laws that legalize the importation of prescription drugs. Other states are considering similar legislation. Legislators in those states believe that drugs can be safely sourced from Canada at costs lower than U.S. prices. These new state laws conflict with and undermine our country鈥檚 in-progress national legislative and regulatory system for tracking and tracing drugs. This system was established six years ago to stop counterfeit drugs from entering the U.S. supply chain. We estimate that manufacturers, wholesalers, and pharmacies will ultimately spend billions to build this system, which is scheduled to be fully operational by 2023. (Adam J. Fein and Dirk Rodgers, 7/11)

Two things became apparent this week after a federal judge blocked President Trump鈥檚 requirement that drug prices be disclosed in TV commercials 鈥 a move intended to shame pharmaceutical companies into being friendlier to patients. First, the ruling highlighted the limitations of Trump鈥檚 I-don鈥檛-need-no-stinking-Congress approach to policy. Once again a court has ruled that Trump exceeded his authority. Second, pharmaceutical companies have no interest in being friendlier to patients. (David Lazarus, 7/12)

The Orphan Drug Act was passed by Congress more than 36 years ago, at a time when rare diseases were often shunted by the research and development community. The act designated 鈥渞are diseases鈥 as those with fewer than 200,000 patients in the United States and for which there was little or no commercial viability to develop and bring to market a cure. It included tax credit incentives for drug evaluation expenditures, as well as limited-marketing exclusivity. (Robert Desnick and Desiree Lyon, 7/11)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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