Food and Drug Administration Commissioner Margaret Hamburg told the Food and Drug Law Institute’s annual conference that the agency is considering opening the files on failed drug and device products to rival firms and independent researchers. This is a long-overdue change that would improve the efficiency of research and development.
“There may be multiple sponsors following development pathways that, based on experience, we know will fail,” Hamburg said, according to an article in today’s FDAWebview (subscription required). “Although some companies may resist disclosure of information resulting from their failures, we hope they would realize that, over time, they could also benefit from the knowledge shared in this manner.”
A questioner pressed Hamburg on whether the agency would unilaterally disclose this data over industry or firm objections. “This is a conversation we’re having,” she replied.
Let’s not forget who else should be part of the conversation — the patients who agreed to participate in the clinical trials that determined the drug didn’t work or was unsafe. These people donated their time and in some cases their lives to the advancement of medical science. They agreed to take risks and, in double-blind placebo controlled trials, the 50 percent chance of forgoing treatment. This is why it is often difficult to recruit patients to participate in clinical trials. Both basic morality and scientific ethics dictate this data become public.
The fact that companies usually paid for the trials gives them a proprietary interest in the data, no doubt. But patients also have rights in this situation, which even a court of law ought to recognize.
The author, Merrill Goozner, is an award-winning journalist and author of ’The $800 Million Pill: The Truth Behind the Cost of New Drugs’ who writes regularly at Gooznews.com.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
