“Our system has been a huge success, but those who want to take us back to the pre-Bayh-Dole era are saying that the government is giving developers an unfair advantage over the inventions that the government helps create. It is clearly false.”
Just when you think you have enough to worry about, you stumble upon something else. In that wisdom, Congress enacted the Medicare Drug Price Negotiation Plan as part of the Inflation Reduction Act. The program begins by imposing a “maximum fair price” for medicines as determined by the Centers for Medicare & Medicaid Services (CMS).
In setting these prices, Congress included factors such as research and development costs for each drug, whether they were recalled, and current production and distribution costs for the drugs in question. But it was his third criterion that caught my eye. “Advance federal funding for the discovery and development of new therapeutics for this drug.”
Hopefully CMS is smart and recognizes that when companies develop new drugs containing patents created with federal backing, they do not gain any unfair advantage over their competitors. CMS is part of the Department of Health and Human Services, which also includes the National Institutes of Health (NIH). As the NIH can attest, unless companies incur the enormous risks and costs of acquiring early-stage inventions from academic laboratories and federal laboratories, these discoveries will only become obsolete. This is exactly what happened before the Bayh-Dole Act provided the necessary incentives for her public-private R&D partnerships, making the United States the undisputed global leader in life sciences. And, as the NIH knows all too well, most of the time these projects fail and companies take a hit, often losing billions of dollars.
Further making this process less attractive by penalizing the few successful drugs that make it through the system is a very bad idea. -Filed the following on behalf of the Dole Coalition:
“Thank you for the opportunity to comment on the initial guidance for implementing Medicare’s drug price bargaining provisions of the Controlled Inflation Act.
As you consider how to proceed, it’s helpful to remember the adage, “First, do no harm.” The issue of making medicines more affordable goes far beyond the scope of the Bayh-Dole Coalition, but it poses a very real danger to our ability to continue to lead the world in creating life-saving treatments. One factor stood out as bringing about a This is a grave error that can do irreparable damage to the world’s most innovative system. NIH should know this better than anyone.
Prior to 1980, governments took inventions from inventors. When President Johnson asked the Secretary of State why medicines aren’t made from the billions of taxpayers who fund NIH research, the answer was that the private sector would take on tremendous risks and development costs. It was that the incentives necessary for That discovery ultimately led to the passage of the Bayh-Dole Act, which restored the incentives in our patent system necessary for effective public-private partnerships. These alliances make the United States the undisputed leader in the life sciences.
Partnerships between our academic institutions, federal laboratories, and the private sector are important, but industry bears the risks. These risks are particularly acute for SMEs that drive innovation, especially when it comes to developing new drugs. The United States is the only country in the world where small companies routinely play a significant role in the development of breakthrough new medicines.
Despite the great success of our system, those who seek to revert us to a pre-Bayh-Dole era claim that we are “risking” government-assisted creation of inventions, and that developers giving an unfair advantage to
The government’s findings are nascent and more like ideas than products. This is especially true for new drug development. A new study, “The Relative Contribution of NIH and Private Sector Funding to New Biopharmaceutical Approvals,” examines his NIH and industry investments in 18 of his FDA-approved treatments that cited NIH-backed inventions. bottom. NIH funded him $670 million against $44.3 billion industry dollars. And even that can be misleading, as the majority of new treatments fail in the development pipeline.
Another fallacy is that companies are trying to partner with the NIH or academic research centers. As the people running your program will attest, most of the time it is very difficult for him to find even one company willing to take on the burden of bringing government-funded inventions to market. This is especially true in drug development due to the enormous expense, decades of research required and the uncertainty associated with obtaining FDA approval. No company gets the “express lane” because they work on government-backed inventions.
One of the United States’ key advantages over foreign competitors is that the United States system provides the power and incentives for entrepreneurial companies to develop government-funded inventions. This will make federal programs more effective without burdening taxpayers. Companies take on this burden knowing they are at a disadvantage. If we want to continue to be a marvel of innovation in the world and a source of new drugs and other treatments, we absolutely must avoid adding to that burden.
For these reasons, I urge you not to take advantage of the fact that companies have far exceeded expectations when negotiating Medicare drug prices. Any short-term price reduction benefits are largely offset by those leaving his NIH and research university affiliations in the future.
That’s a price we can’t afford to pay. ”
