Loyola University Chicago School of Law, JD 2017
Bioethics International (BEI), a non-profit organization, is working to improve transparency and ethics in healthcare delivery and innovation by holding pharmaceutical companies accountable for compliance with the Food and Drug Administration Amendments Act (FDAAA). Many people do not trust drug companies, believing Big Pharma is unethical and more concerned with profits than people. Jennifer Mills, founder and president of BEI, believes that greater transparency will improve public health Big Pharma regain consumers’ trust and help physicians prescribe new drugs. The Big Pharma Scorecard is a new, unique way to improve compliance by creating a “knowledge exchange platform” to encourage change.
According to Dr. Miller, disclosing the results of clinical trials helps participants feel like they are contributing to general knowledge and being honored for their participation. Altruism is one of the biggest reasons research subjects choose to participate in clinical trials. Maintaining a large pool of research subjects is important to healthcare innovation. Disclosure of any safety concerns is also important in protecting participants in future studies for similar drugs. In addition to participants, patient advocacy groups are likely to be interested in this information. Further, physicians are more likely to prescribe new drugs when there is more clinical trial transparency. Physicians follow prescription guidance based on public evidence, and feel more comfortable relying on guidance when there is greater disclosure. Physicians need all of the medical information about safety and efficacy of a drug. If the information disclosed is incomplete, the guidelines will also be incomplete. Transparency also benefits public health by providing more evidence-based treatments and fostering greater trust in the pharmaceutical industry. Some patients, particularly minority and elderly populations, are reluctant to take prescribed medications because they distrust pharmaceutical companies.
FDAAA governs clinical trial transparency. Under the FDAAA, clinical trial sponsors, or Principal Investigators in some cases, are responsible for registering applicable clinical trials and submitting the results. Applicable clinical trials are generally controlled or interventional studies for FDA regulated drugs, biologics, or devices that meet certain conditions. The FDAAA applies very narrowly to just seventeen to twenty-four percent of clinical trials seeking regulatory approval of a drug. However, there is still a high degree of noncompliance with the law. BEI works with drug companies to find out why compliance is low. There have been a variety of interpretations of the law. There has been some debate over whether the law applies to interventional (studies of unhealthy patients) versus controlled studies. There was also debate over how to define interventional studies and controlled studies. But Dr. Miller’s research has shown that it is unlikely noncompliance stems from confusion over what constitutes an applicable clinical trial. She has found that there has been a lot of confusion surrounding certificates of delay. The law requires that disclosure of clinical trial results within one year of the trial being over unless you file a certificate of delay. If a company files a certificate of delay, disclosure can be delayed thirty days post approval of the drug or three years past the filing of the certificate. BEI found that if clinical trial information was disclosed, it was most often disclosed thirty days after approval of a drug.
For more recent data, BEI is thinking about adding measures for three months post-approval and six month post-approval, rather than thirteen months post-approval for the 2012 data. Many insurers, including the Centers for Medicare and Medicaid Services, make formulary decisions three months post-approval. BEI also plans to develop better ways for consumers, drug companies, and providers to access information about clinical trial results.
Dr. Miller hopes the industry will begin to use the Scorecard as an auditing and benchmarking system. The Scorecard also presents a new tool for regulators. The Food and Drug Administration (FDA) can impose a $10,000 per day penalty for failure to disclose clinical trial information where it is required by law. President Joe Biden has also recently threatened to cut funds for researchers that do not file clinical trial results. He was concerned after learning of a study which revealed most research institutions, including drug companies and some of the leading hospitals and universities, have violated the FDAAA, putting patients at risk when doctors did not have complete information to gauge the safety and benefits of new treatments. The FDA has not been imposing penalties for these violations, but the federal government could have collected $25 billion from drug companies alone over the last seven years. The Scorecard could help regulators monitor and enforce the FDAAA by benchmarking compliance with the law and helping the federal government determine how to focus its efforts and resources.
The Scorecard is an innovative way to encourage compliance. Rather than penalizing noncompliant drug companies, BEI works with them and holds meetings that give drugs companies an opportunity to learn from each other and share ideas. BEI sends companies their data before disclosing the information to the public, to give drug companies a chance to respond and provide feedback. This program had a one hundred percent response rate for the 2012 data and BEI invites the companies to meet a couple times a year to discuss reasons for noncompliance and best practices that high-scoring companies have implemented. Dr. Miller found that many companies do not realize that they are doing things differently from each other. Trade associations are also beginning to adopt the Scorecard’s benchmarks to improve standards among members. Although drug companies are still likely to be influenced by money and profits, Dr. Miller is hopeful that the Scorecard will motivate drug companies to devote more resources to achieving greater transparency.