Drug companies typically don’t tell investors why the FDA rejected their drugs, a new British Medical Journal report has revealed. They just breeze over the details in press releases — frequently withholding whether a drug in clinical testing, say, caused patient deaths.
The study covered new drug applications and biologics licensing applications between August 11, 2008 and June 27, 2013. In this timeframe, seven medications were rejected because patients taking the drug had a higher likelihood of dying than those in the control group. Investors and the public were only informed in one instance.
As Matthew Herper of Forbes points out:
Behavioral Health, Interoperability and eConsent: Meeting the Demands of CMS Final Rule Compliance
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The conclusion: at best, the industry’s communications about rejections are insufficient and misleading. At worst, they sound close to outright lies – and investors faced with an FDA rejection should never believe anything that executives have to say unless those executives make public the full text of the rejection letter – something that, in the time span of this analysis, no company has done.
Most frequently, omissions are made in regards to the efficacy and safety of the rejected drug. This, of course, is that by law companies needn’t provide these clear details on why a drug was rejected. So when companies put out their 8Ks and their press releases, they hold back on the nitty gritty. Herper continues:
This information vacuum doesn’t just hurt investors. Companies say the letters should remain confidential because they contain competitive information. But the reality is that companies are not served by a system where only a limited number of people know why a drug was rejected. One of the best ways to understand what you need to do to get your drug approved is to know where others went wrong.
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.
