July was an active time in healthcare policy, with promising policy developments on Capitol Hill and in the court system regarding the ability of biopharmaceutical companies to share up to date and accurate information about medicines with physicians and other healthcare professionals. Such information sharing could improve both patient care and the efficiency of our healthcare system.
21st Century Cures
On July 10th, the U.S. House of Representatives passed the 21st Century Cures Act, which was supported by PhRMA and many other advocacy organizations. Two provisions of the Act address the Food and Drug Administration’s (FDA) outdated regulations which prohibit biopharmaceutical companies from sharing certain accurate, data-driven information with healthcare providers and payers to inform patient care.
One provision seeks to allow biopharmaceutical companies to share pharmacoeconomic data with medically sophisticated audiences such as formulary committees and insurers which select medications for coverage or reimbursement. Access to this additional information could help these entities compare alternatives and select the optimal therapies for improved patient outcomes and greater efficiency.
Dr. Scott Gottlieb, formerly Deputy Commissioner of FDA, recently addressed the need for updated FDA regulations to encourage the development and dissemination of this type of information in a Forbes column: “Yet the importance of enabling the generation and sharing of economic information about drugs is only increasing. The market is demanding more of this information. Absent a viable path to share this information, it follows that there will simply be less of it. This will reduce competition, and leave consumers, physicians, and the entities that purchase medicines with less information to inform their decisions.”
Another provision in the Act would require the FDA to issue draft guidance on the ability of biopharmaceutical research companies to communicate accurate, scientific information on approved medicines. This provision may create an opportunity for manufacturers to provide more information about certain medically accepted alternative uses of products, where evidence is most likely to be lacking and manufacturers can fill a needed knowledge gap.
As the legislation and discussion move to the Senate, we must continue to focus on improving health outcomes through more informed clinical practice.
Legal Developments
In early July, oral arguments were heard in the case of Amarin Pharma v. FDA, in which the company is arguing that FDA’s restrictions on the ability to share information about Amarin’s clinical trials violates the First Amendment. “The FDA’s ‘speech as evidence’ argument doesn’t fare well when subjected to real scrutiny,” writes Cozen O’Conner, legal blogger at Lexology. “No matter how argued, this notion runs up against the reality that it involves a regulatory regime that bases criminal liability, in many instances, solely on truthful, non-misleading speech.”
Another issue of concern within this case and the broader debate about healthcare information is the impact the FDA’s regulatory framework has on the overall quality of healthcare. Healthcare analyst John Osborn wrote in Forbes that, “nearly everyone in the healthcare system – doctors, patients, medical researchers, payers, providers – is free to discuss the clinical data and the off label utility of products except for the folks who presumably know more than anyone else about the product profile.” He argues that the government’s lack of clear guidance to the industry in this area creates unacceptable confusion and barriers for patients and physicians.
An amicus brief filed by PhRMA argues that the FDA’s current regulations on information-sharing with healthcare professionals are “highly detrimental to physicians and to patients, who benefit from having truthful and non-misleading information about medically accepted, unapproved uses available to them.” For that reason, the brief notes, “The Court should act to prevent the censorship the Government proposes in this case.”
PhRMA continues to encourage the FDA to work with biopharmaceutical research companies, healthcare providers, patients and other stakeholders to create a modernized regulatory framework that encourages the development and dissemination of accurate, data-driven information. Making more comprehensive and up to date information available to healthcare providers and payers would improve patient care and increase the efficiency of the healthcare system.
