Time to Update Legislation Regarding Distribution of Healthcare Economic Information

Legislation regarding the promotion of healthcare economic information is outdated and does not reflect the changes that have occurred since the FDA Modernization Act (FDAMA) was passed in 1997, contended speakers at the Academy of Managed Care Pharmacy’s 2016 Nexus, held in National Harbor, Maryland, October 3-6.

According to Daniel C. Malone, RPh, PhD, FAMCP, professor at the University of Arizona, since the legislation passed, there has been a tremendous growth in economic studies and a growing need to show value for innovative products, plus patients are becoming more engaged and want to have a say in how drug information is released.

The controversy with FDAMA Section 114 is the undefined terminology used, he explained. The way “healthcare economic information,” “competent and reliable scientific evidence,” “directly relates,” and “audience” are used in the language of the legislation but never defined creates a lot of gray areas today, Malone said.

In researching articles in PubMed with “cost-effectiveness” in the title or abstract, Malone found that since the law was passed in 1997, there has been “a tremendous uptick” in the number of articles each year that have to do with cost-effectiveness. Yet, when analyzing the types of evidence in Pharmacy and Therapeutic drug monographs, Malone determined that real-world evidence studies only represent 4.8% of the studies used.

“Perhaps the evidence might be generated, but it’s not reaching the decision makers at the time the decisions are being made,” he said.

Jeffrey K. Francer, JD, MPP, vice president and senior counsel for PhRMA, outlined the legal issues of FDAMA Section 114 and recent developments that could lead to updating the FDA’s regulations of communications between pharmaceutical companies and various stakeholders.

He outlined 3 main reasons why discussions about updating FDAMA section 114 are happening now:

1. Evolution in our healthcare system where cost effectiveness is becoming more important than ever as stakeholders search for value in order to provide the best treatments for patients at the best price.
2. Evolution in First Amendment jurisprudence throughout various courts, from the Supreme Court down through circuit courts.
3. Current FDA regulations are becoming outdated since they were based on a paradigm of findings of safety and effectiveness based purely on randomized controlled trials.

“More than ever before … we see healthcare professionals payers and other stakeholders seeking more information, and not less, about the safety, effectiveness, and value of treatments,” Francer said. “And there is more and more information out there.”

If payers and providers can only rely on information on the drug label, the information can become outdated, he added. There are a number of other sources of information outside of the FDA-approved drug label, such as clinical practice guidelines, post-market safety and effectiveness data, peer-review journal articles, economic impact information, and real-world evidence.

Francer said that PhRMA believes a new regulatory framework is necessary, and it looks like the courts will end up pushing the FDA to change if the agency doesn’t make changes on its own. He pointed to a few recent cases where the courts had ruled on companies’ ability to communicate information. The First Amendment rulings that have come down are raising questions about some of the FDA’s regulations and enforcement, he said.

First, there was Sorrell v IMS Health in 2011, which involved a Vermont low that prohibited companies from using prescriber data for commercial activity. The Supreme Court ruled on the case that the government cannot allow a type of speech for one party, but prohibit it for another party.

In US v Caronia (2013), a court ruled on off-label promotion. A sales representative had been caught by the FBI for mentioning studies that were not in the approved labeling. He was prosecuted for providing the information, not because the information he provided was inaccurate. The court held the “government cannot prosecute … for speech promoting the lawful, off-label use of an FDA-approved drug.”

Finally, Francer provided principles on responsible information sharing as created by PhRMA and BIO. There are 3 main principles:

1. Science-based communication Information from studies other than randomized controlled trials can be considered science based.
2. Appropriate context about the data Companies should be able to provide information with adequate scientific substantiation even if the shared information is not contained in the FDA-approved labeling.
3. Communication tailored to the intended audience There is a difference between speaking with payers who understand the data and a general practitioner. The intended audience should be able to accurately understand the information and be able to incorporate it into their existing body of knowledge and expertise.