An in depth report by CNBC looks at the issue of big pharma exploiting orphan drug status to generate huge profits for blockbuster medications. It highlights a new study by Johns Hopkins University School of Medicine which is raising concerns. Here is an excerpt:
A new study from Johns Hopkins University School of Medicine questions whether some of the biggest drug companies and their blockbuster medications are taking advantage of a decades-old act meant to increase research, development and drug approval for people suffering from rare diseases.
Drugs approved by the Food and Drug Administration as “orphan drugs” have seen sales increase from $46.6 billion in 2014 to $54 billion this year in the U.S. alone and are projected by drug industry consultant EvaluatePharma to reach above $60 billion in 2016. Worldwide, orphan drug sales are forecast to total $102 billion this year and $178 billion by 2020.
The 41 percent of all FDA approvals for new drugs in 2014 that were designated orphan drugs compares to six orphan drug approvals of a total 30 new drugs approved by the FDA in 1985 (two years after the Orphan Drug Act, also known as the ODA, was passed).
In 1983, the United States Orphan Drug Act (ODA) was passed in the hope that with more research and a faster approval process, new drugs could be available for “orphan diseases,” meaning those that affect less than 200,000 people. The ODA offers drug makers incentives to find treatments for rare diseases, including grants, tax incentives and extension of exclusive marketing rights to a drug for seven years.
“The loophole means more monopoly power for pharma companies selling common drugs that were snuck through the FDA as orphan drugs,” Dr. Marty Makary of Johns Hopkins, the lead researcher and senior author of the study, told CNBC.
Click here to read the full article. This is the very issue exposed in the James Hoyer case against Endo Pharmaceuticals, which ended with the company returning some $193 million to the public coffers.