The FDA published a list yesterday of 235 approved medicines that may have benefit other rare disorders for which they are not currently approved, named the Rare Disease Repurposing Database (RDRD). FDA’s motive is to encourage drug makers to examine other potential indications for approved drugs already on the market.
The initiative is spearheaded by Tim Cote, head of the agency’s Office of Orphan Product Development who is taking the industry to task. “Large pharmaceutical companies are not as engaged as we’d like to see them be,’’ Cote said in a phone interview.
About 30 million Americans have one of 7,000 rare diseases for which there are few or no treatments. Medicines developed to treat these conditions are called orphan drugs, under rules which lengthen the IP protection of such drugs to encourage their development. More often than not, indications with nominal revenue potential are overlooked by companies who operate as for-profit businesses. Looking over the list, you’d be hard pressed to find a leading pharmaceutical company that goes unnamed.
So, it begs the question: what is the ethical responsibility of for-profit pharmaceutical & biotechnology companies to invest in products that may potentially help patients…but only a few?
