With only a week to go before the Nov. 8, 2022 midterm election in the U.S., speculation is growing over what the 118th Congress will look like and what it will mean for the biopharma and med-tech industries. If Republicans flip either chamber, it would prevent either party from using the reconciliation process, which requires the barest majority in the Senate, to pass legislation such as the Inflation Reduction Act with its provisions giving the federal government some control over prescription drug prices.
The Biden administration has released a blueprint for an artificial intelligence bill of rights, which is accompanied by an acknowledgement that these algorithms can be crucial in guiding treatment of cancer patients.
Regulation of advanced therapies has come under scrutiny at a conference in London, as activity in the sector heats up amid Europe’s root and branch review of pharmaceutical legislation.
“It’s now law,” U.S. President Joe Biden said after he signed H.R. 5376 Aug. 16. His signature made Medicare drug pricing negotiations a near-term reality, along with new inflationary rebates, new caps on annual out-of-pocket drug spending and monthly insulin copays for Medicare beneficiaries, and tax changes that could affect the bottom line for several multinational drug and device companies beginning next year.
As expected, the U.S. House of Representatives passed, on a 220-207 party-line vote, a legislative package Aug. 12 that, for the first time, allows Medicare to directly negotiate some prescription drug prices, while imposing severe penalties and an excise tax on companies that refuse to negotiate or don’t comply with the government price.
Within a few weeks, government price negotiations for some prescription drugs, as well as limits on annual price increases, could be the law of the land in the U.S. With the Senate passing a slimmed-down version of H.R. 5376 through reconciliation Aug. 7, the House is expected to make a brief return Friday from its August recess to vote on the changes and conference the differences between its bill and the Senate version. Then it’s on to the president’s desk for the signature that will enact the package of health care, tax and climate provisions.
No one denies that fewer new drugs will be a consequence of the Medicare drug pricing provisions the Democrats are trying to push through the U.S. Congress ahead of the midterm election campaign season. Less attention has been paid to the negative impact on drug-device combinations and new diagnostics that accompany innovative treatments.
No one denies that fewer new drugs will be a consequence of the Medicare drug pricing provisions the Democrats are trying to push through the U.S. Congress ahead of the midterm election campaign season.
As Democrats in the U.S. Senate rush to pass prescription drug pricing reforms through the reconciliation process this week, the nonpartisan Information Technology & Innovation Foundation (ITIF) is offering Japan’s experience with government price controls as a cautionary tale.
As Democrats in the U.S. Senate rush to pass prescription drug pricing reforms through the reconciliation process this week, the nonpartisan Information Technology & Innovation Foundation (ITIF) is offering Japan’s experience with government price controls as a cautionary tale. “Stringent drug price controls have significantly hampered the competitive and innovative capacity of Japan’s biopharmaceutical industry in recent decades, serving as a warning for U.S. policymakers considering introducing Medicare Part D drug price controls in 2022,” according to the ITIF.
