President Trump’s insulin executive order is unlikely to take effect before the election.

‍HHS has decided not to expedite the rulemaking for Trump’s insulin order. The order was intended to make health centers directly give patients the discounts that the centers get on insulin and injectable epinephrine through 340B. However, after dozens of health centers complained that the order would have the opposite effect on prices, HHS opted to use the traditional notice and comment rulemaking process. To read the full article, click here.

The FDA completed the rulemaking to allow states to import drugs from Canada.

‍The final rule allows FDA-authorized programs to import certain prescription drugs from Canada under a set of specific conditions to ensure no additional risk to the public’s health is sacrificed in an attempt to lower drug prices. The rule allows states, DC, territories, and Native tribes to submit importation proposals to the FDA. The final rule also gives room for importation proposals to be received by pharmacists and wholesalers in the future. To review the FDA press release, click here.

• To read the complete rule, click here.
• To review the final guidance for the industry, click here.

Only some seniors are expected to get their $200 Medicare drug cards, or ‘Trump Cards’ before the election.

‍The HHS Chief of Staff announced that the cards will be going out as soon as possible, but it will take several months for every senior to receive their card. There is still significant discussion on how the cards will be paid for. Trump has mentioned that the savings from the most favored nation demonstration will cover the cost of the cards, but the order has not yet been implemented and relies heavily on the ACA, which the administration is attempting to repeal. Other officials have said the cards may not need to be paid for, under section 402 of the Social Security Act. To review the full article, click here.  

Researchers from Perelman School of Medicine at UPenn published their evaluation of drug reimbursement policies from 6 peer countries in JAMA.

‍As the election nears, researchers investigated what other countries’ policies look like to keep drug spending down. The US accounts for4.5% of the world population, yet more than 40% of global drug spending. The drug pricing policies and government regulations from Australia, France, Germany, Norway, Switzerland, and the United Kingdom were compared to three current US bills in Congress. The researchers found that while the bills may have similar elements to policies found in the peer countries, none were as comprehensive as the peer countries’ policies. To read the full study, click here.

A Health Affairs blog post by Suffolk University law professor examines the average international market pricing for US pharmaceuticals in Europe.

‍The post highlights how the European price index is inherently different from the US proposals of an international price index (IPI), and to reduce drug spending the US should model policies after the European method. The main point of the research shows that the IPI should be based off of real maximum reimbursements and not the official prices to be effective in reducing drug spending. Even then, the IPI must be used as part of a larger cost-control strategy to be as effective as possible. To review the full post, click here.

Upcoming: The House Oversight Committee announced there will be two days of hearings with top drug manufacturing executives next week. The hearings: “Unsustainable Drug Prices:  Testimony from the CEOs” will be held on Wednesday, September 30th and Thursday, October 1st. To review the press release, click here.

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