- In response to a critical article in The Washington Post accusing the pharma industry of straying from the initial intentions of the Orphan Drug Act, BIO President Jim Greenwood fought back in an op-ed.
- The article describes how since the law was passed in 1983, pharma companies have increasingly sought to develop and market drugs for so-called orphan diseases. Rather than acting as a spur for drug development in rare diseases, some contend the process has become a way for pharma companies to charge excessively high prices for drugs, while enjoying a longer period of market exclusivity and tax credits.
- Greenwood argues the Orphan Drug Act has been a success, citing the fact that 400 orphan drugs have been approved since the act's inception, compared with 34 prior to its enactment.
The public outrage over drug prices that are considered too high by a large majority of the population has only grown since the Turing Pharma scandal last year, with many weighing in on the causes and contributing factors.
Orphan drug prices have received renewed scrutiny, and the Washington Post article holds up the example of Alexion's Soliris as an extreme example. Soliris lists for an annual price of $488,000.
As part of a more high-profile public relations push, BIO is fighting back. Greenwood argued the incentives associated with the Orphan Drug Act have spurred innovation and prompted companies to take on the risk developing drugs for small populations, even when the chances of R&D failure are high and the cost of development is high.
Greenwood cites a BIO study showing the positive impact of the law. "According to the study,.there would have been one-third fewer orphan drugs on the market treating patients with rare diseases over the last 30 years without the incentives found in the Orphan Drug Act," he writes.
The tenor of Greenwood's post is that of silver lining. "By any measure, the Orphan Drug Act has been a resounding success and given hope to millions of families. Let’s not harm the system that has made this success possible," Greenwood said.