Tag: prescription drugs

President Biden announced, in a statement on the White House website, about new actions to lower health care and prescription drug costs. The statement was posted on December 7, 2023. Here are some key parts of it:

President Biden believes that health care should be a right, not a privilege. For too long, corporate special interest and trickle-down economics have allowed Big Pharma to make record profits, while millions of Americans struggle to afford health care and prescription drugs to treat common and chronic conditions.

As part of the President’s Bidenomics agenda, the Biden-Harris Administration is cracking down on price gouging and taking on special interests to lower costs for consumers and ensure every American has access to high-quality, affordable, health care.

Specifically, the Biden-Harris Administration will release a proposed framework for agencies on the exercise of “march-in-rights” on taxpayer-funded drugs and other inventions, which specifies that price can be a factor in considering whether a drug is accessible to the public.

What does “march-in-rights” mean? According to the U.S. Department of Commerce’s National Institute of Standards and Technology (NIST), “march-in-rights” is a tool to help agencies evaluate when it might be appropriate to require licensing of a patent developed with federal funding. The draft guidance will help agencies work through a range of policy considerations relevant to a potential march-in-decision, including price.

This comes after previous actions by the Administration that lowered the cost of insulin at $35 per product per month for seniors, finally allowing Medicare negotiate to lower prescription drug prices, requiring drug companies to pay rebates to Medicare if they raise prices faster than inflation, and locking in $800 per year in health insurance savings for 15 million Americans under President Biden’s Inflation Reduction Act.

Here is the short version of what the Biden-Harris Administration is doing:

• Promoting equitable access to lower-priced taxpayer-funded drugs.

…The Biden-Harris Administration believes taxpayer-funded drugs and other taxpayer-funded inventions should be available and affordable to the public. When an invention is made using taxpayer funds, under certain circumstances march-in authority under Bayh-Dole Act enables the federal government to license the invention to another party…

• Launching a cross-government public inquiry into corporate greed in health care.

The Biden-Harris Administration believes that the health care system should serve patients, not corporate profiteers. The Administration is concerned that our health care system is increasingly being financialized, with corporate owners like private-equity firms and others maximizing their profits at the expense of patients’ health and safety, while increasing costs for patients and taxpayers alike.

The Department of Justice (DOJ), the Federal Trade Commission (FTC), and HHS will issue a joint Request for Information to seek input about how private equity and other corporations’ increasing power and control of our health care is affecting Americans…

• Increasing ownership transparency.

HHS, through the Centers for Medicare & Medicaid Services (CMS), has taken unprecedented action to shed light on ownership trends in health care. The Biden-Harris Administration is the first to make ownership data on hospitals, nursing homes, hospice providers, and home health agencies publicly available, and today, CMS is releasing, for the first time, ownership data on Federal Qualified Health Centers and Rural Health Clinics on data.cms.gov…

• Increasing Medicare Advantage transparency.

Currently, about 50% of Medicare enrollment is in Medicare Advantage and the government is expected to spend over $7 trillion on Medicare Advantage over the next decade. The Biden-Harris Administration is committed to ensuring Medicare Advantage insurance plans best meet the need of people with Medicare, there is timely access to care, and the market has healthy competition…

• Negotiating and lowering drug prices.

Thanks to President Biden’s Inflation Reduction Act, the Administration has announced 10 prescription drugs for which Medicare will negotiate prices directly with participating manufacturers. These drugs cost people with Medicare $3.4 billion out of pocket in 2022. This builds on other progress to lower prescription drug costs.

Individuals with Medicare can now receive certain vaccines for free under the President’s lower cost prescription drug law, which previously would have a cost of an average of $70 in out-of-pocket costs…

• Stopping Big Pharma tactics that raise prices for working families.

In September, the FTC issued an enforcement policy statement explaining that Big Pharma companies may face legal action if they delay entry of generic competitors with improper patent listings in the Food and Drug Administration’s (FDA’s) publication “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the “Orange Book.”

When a brand pharmaceutical company improperly lists a patent in the Orange Book, it may lead to a 30-month statutory stay that blocks the approval of competing drug products, including lower-cost generic alternatives. Some improper listings may delay competition and raise prices for live-saving products like asthma inhalers…

In addition, the Biden-Harris Administration is cracking down on anticompetitive and anti-consumer practices in Medicare Advantage, making hearing aides available over the counter, and cracking down on nursing homes that endanger resident safety.

President Biden also recently signed a bipartisan law, the Securing the U.S. Organ Procurement and Transplantation Network Act, to break up the monopoly that has controlled the organ transplant system for its entire nearly four decade history.