Dear Chairman Sanders, Ranking Member Cassidy, and Members of the Committee:
The American medical innovation infrastructure that has saved and strengthened countless lives through the development of medicines and medical technologies is dependent upon a strong, robust intellectual property (IP) system. At a time in which America is facing unprecedented competition from China and other nations in the development and manufacturing of new treatments and technologies, it is essential for policymakers to not only protect but also maximize the impact of our intellectual property. Unfortunately, we are continuing to see policymakers consider legislation that threatens the IP infrastructure that has enabled the US to become the leader in health care innovation.
Our organization, We Work For Health, brings together national and local business leaders as well as stakeholders from labor, biopharma, the patient advocacy community and other healthcare sectors to support policies and initiatives that foster innovation and facilitate the delivery of lifesaving and life-enhancing medicines. We welcome the opportunity to support the committee’s work on behalf of American patients and health care consumers.
We write to urge you and your colleagues on the Senate HELP committee to reject two pending bills, the Biosimilar Red Tape Elimination Act (S. 2305) and the Medication Affordability and Patent Integrity Act (S. 2780). In different ways, both bills would have an adverse effect on the nation’s efforts to protect and maximize the utilization of intellectual property and Americans' access to innovative therapies.
The Biosimilar Red Tape Elimination Act is ostensibly aimed at reducing the barriers to introducing new biosimilars into the marketplace. It would deem all biosimilars as interchangeable with the original reference product without requiring a determination by the Food and Drug Administration (FDA) as to possible risks to patient safety. The bill’s sponsors argue that removing the requirement for FDA studies will get biosimilars to patients more swiftly.
This bill, however, is both unnecessary and potentially harmful to future development of biologic medicines. Under current law, additional studies are not required to determine interchangeability. The FDA already has the latitude to require studies or decide they are not necessary based on the agency’s scientific judgment. In fact, the FDA has recently licensed numerous interchangeable biosimilars without requiring studies. FDA should continue to have this discretion in order to ensure safety and efficacy of new products.
We urge the committee to consider the impact on medical innovation in its deliberations on this bill. Tying the FDA’s hands, as S.2305 would do, will make it more difficult for the agency to approve more complex biosimilars in the future because it would be restrained in conducting the studies necessary to determine the risks of switching between the reference product and the new biosimilar. This would be an imprudent step in an area of science that is rapidly evolving. For the committee to make biosimilars more accessible to patients, a more effective step would involve addressing the practices of pharmacy benefit managers (PBMs). Not only do PBMs regularly exclude biosimilars from coverage in order to steer patients toward more expensive drugs that generate greater PBM profits, they have also recently delved into biosimilar manufacturing themselves, occupying the manufacturer, insurers, negotiator, and middleman roles all at once and driving patients to self-serving profits.
The Medication Affordability and Patent Integrity Act raises a different set of concerns regarding the protection of intellectual property. This measure adds significant new reporting requirements involving the information biopharmaceutical companies must provide to the U.S. Patent and Trademark Office (USPTO), supposedly to prevent the USPTO from issuing patents for “inherent” aspects of drugs.
An already overburdened USPTO, under this legislation, will be forced to handle volumes of new information, further slowing its examination of processing of patents. Worse yet, drug companies would be required to share highly confidential information and trade secrets with the USPTO, even though this information is already with the FDA as part of the drug approval process. This risks public exposure of this information, making it vulnerable to our foreign adversaries and risking a detrimental effect on global competitiveness. And all of this is entirely unnecessary because current law already penalizes companies if they seek to deceive the USPTO, rendering their patents unenforceable.
We appreciate the committee’s efforts to make prescription medications more accessible and affordable for patients, and share that goal. These two bills, however, would not accomplish these objectives, and instead would undermine innovation. What these bills are seeking to achieve is already enshrined in current law. More troublesome, though, is that these bills would make America’s invaluable intellectual property less secure and less effective in meeting patients’ healthcare needs. We appreciate the committee’s consideration and look forward to working with you in achieving our shared goals.
Sincerely,
Dan Leonard
Executive Director
We Work For Health