HHS has budgeted $60 million to develop generic drug making technology for essential medicines.

In an effort to secure the drug supply chain, the Biden administration is moving to manufacturer more essential medicines domestically, rather than overseas in China and India. HHS has moved to build upon existing public-private partnerships to establish a list of 50-100 critical drugs, from the essential medicines list, to begin manufacturing in the US.  The report also urges Congress to give the FDA more authority to collect tracking data throughout the drug supply chain and outlines a new rating system for manufacturers’ quality management systems. To read the full press release, click here.

Senate Democrats, led by Sen. Ron Wyden (D-OR), continue to write a more moderate alternative to Speaker Pelosi’s drug pricing plan.

Wyden has not released any details on his plan but has said that negotiation will be included in the upcoming bill in some way, however it is not likely to include the international reference pricing provision. Meanwhile, Senate Majority Schumer (D-NY) has also been seen to be meeting with key stakeholders. To read the full article, click here.

A STAT analysis found that over two thirds of Congress accepted donations from pharmaceutical companies ahead of the 2020 elections.

The largest donors were Pfizer and Amgen, each of which donated to over 200 lawmakers. While drug companies gave to a wide range of candidates on both sides of the aisle, most of the donations were given to lawmakers that sit on key health care committees. To read the full report, click here.

The state of Mississippi sued PBMs and drug manufacturers over the price of insulin.

The state claims that manufacturers were given placement on formularies due to illegal rebates to PBMs. The complaint cites that Mississippi pays approximately $3.5 billion for caring for constituents with diabetes and that these illegal rebates have caused the state to pay millions more than it should have to. The lawsuit is the first to target both PBMs and insulin manufacturers. To read the full complaint, click here.

Researchers from Johns Hopkins Bloomberg School of Public Health analyzed “ultra-expensive” drug spending in Medicare Part D in a recent Health Affairs article.

The study looked at Part D’s share of spending on drugs that have an average annual per beneficiary total spending in excess of annual GDP for that year (ultra-expensive drugs), from 2012-2018. Researchers determined the main reason for the increase in spending on ultra-expensive drugs was due to increasing numbers of beneficiaries on the drugs. One concern discussed in the article is that many of these drugs enter the market already priced as ultra-expensive with no demonstrated therapeutic or economic benefit. To read the full article, click here.

CIDSA Experts in the News

Ge Bai, Sean Dickson, Stacie Dusetzina, and Rachel Sachs spoke with reporters for MarketWatch on how Medicare seniors are paying the highest price while waiting for Congress to address high drug prices. Dusetzina stressed that only limiting out-of-pocket costs would weaken consumer price sensitivity and result in higher prices, premiums, and government spending. Bai spoke out against an upcoming District Court case in New York that will hear Pfizer seek approval for copay assistance programs that will effectively blind patients to true costs, allowing manufacturers to continue to hike prices. Dickson highlighted how 1.1 million Medicare patients could die from the inability to afford their medication. Finally, Sachs discussed how there is no one policy that will effectively address high drug prices. To read the full article, click here.

Sean Dickson spoke with reporters on Gilead’s PrEP medications, Truvada and Descovy, after Gilead announced how they reimburse clinics through assistance programs would be changing. Dickson discussed the implications of Gilead's proposed changes on safety net clinics if Gilead were to only reimburse clinics at the discounted price, rather than the full retail price. To read the entire article, click here.

Stacie Dusetzina spoke with Modern Healthcare reporters on how Aduhelm will be covered by insurance. While the actual out-of-pocket cost for the $56,000 drug will depend on the patient’s plan, patients with Medicare Advantage could risk spending thousands before their insurance kicks in. To read the entire article, click here.

Rachel Sachs wrote on the implications of the approval of Aduhelm across a range of health policy issues in a recent Health Affairs blog post. Sachs highlights the risk of both a broad label designation and the accelerated approval pathway for aducanumab. Throughout the article, she emphasizes how this approval could cause a loss of trust in the FDA and their approval process. To read the full article, click here.

• Sachs also spoke with Washington Post and Bloomberg reporters on the impact that Aduhelm could have on health care spending. To read both articles, click here and here.