The butterfly effect is an elegant analogy to describe the seemingly unpredictable and far-reaching implications of a relatively small and inconsequential event. The FDA’s approval of Aduhelm is not so much a butterfly gently flapping its wings, but rather a sonic boom emanating from a jet engine. Most immediately, it provides a new therapeutic option for millions of patients in dire need of hope, vindicating Biogen’s faith with a revenue stream running into many billions of dollars. Longer-term the reverberations may be felt across the entire industry, throwing into question the evidentiary requirement for drug development.

Some Democratic senators are not fans of FDA’s approval of Biogen/Eisai’s Aduhelm, and are even more critical of the price of the Alzheimer’s therapy. That is providing a new hook to urge action on creating a federal price ‘negotiation’ program – but not any more clarity on a viable path to enacting one.

Ron Wyden points to expectations Biogen’s drug will impose a heavy cost burden on Medicare as he questions FDA’s decision to approve aducanumab. He also expresses interest in a government-sponsored technology assessment program that could help establish the value of drugs.

Two groups of smaller European countries have agreed to collaborate on tackling challenges relating to accessing expensive new medicines.

Senate committee seeks details on company’s international tax practices as congress works to implement President Biden’s proposals on corporate tax reform.

Biden administration asks court to dismiss PhRMA’s lawsuit against Trump-era pathway for drug importation from Canada because FDA has not yet cleared any Section 804 Importation Programs (SIPs). The brief outlines the high hurdles to getting a SIP approved and Canada’s opposition to the programs. It's not clear if the Biden team plans another more feasible route to drug importation.

Legislation would be needed and will be complicated to develop. While the effectiveness of existing audits has been question by a federal government watchdog, the proposal in Biden’s budget document suggests the administration has some sympathy with drug sponsors’ position in the ongoing fight over the 340B drug discount program.

Approach leaves policy development to Congress. The President understands the need to build consensus around specific policies to achieve his goals, White House Office of Management and Budget Acting Director Shalanda Young explains.

The regulatory provisions being challenged are part of a Trump-era “midnight rule” that could be changed by the Biden Administration before implementation, but PhRMA is not taking any chances about the future of copay assistance programs.