Pharma's niche spurs U.S. spending on threats

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WASHINGTON — The pharmaceutical industry won approval to market a record number of new drugs for rare diseases last year, as a combination of scientific innovation and business opportunity spurred new treatments for diseases long-ignored by drug companies.

Drug companies are increasingly taking advantage of the commercial benefits of developing so-called orphan drugs, which include extra patent protections, higher pricing and a streamlined review process by FDA. Among the innovative treatments approved in the past year were the first new drug for lupus in 50 years and the first new drug for Hodgkin’s lymphoma in 30 years.

But the focus on specialty drugs has put pressure on the U.S. government to ramp up its own spending on vaccines, antibiotics and drugs for more widespread health threats, which are less profitable for companies.

Since 2006, government spending on research for familiar diseases like staph infections, smallpox and botulism has increased more than 660 percent, from $54 million to $415 million last year

“Many of these are everyday, general diseases that we thought we had conquered decades ago, but we’ve seen some of them pop up again,” said Dr. Robin Robinson, director of the Biomedical Advanced Research and Development Authority, which is tasked with acquiring vaccines, drugs and other necessities for public health emergencies.

Since 2005, BARDA has awarded $3.5 billion to outside companies to encourage research and production of antibiotics, flu vaccines and other products that are seen as less profitable than specialty drugs.

“We have pushed the envelope more toward diminishing the risk for companies so that they’ll be more interested in getting involved with us and developing things like vaccines and antivirals,” said Dr. Anthony Fauci, infectious diseases chief at the National Institutes of Health, which funds research into bird flu, tuberculosis and other potential pandemics. The government’s role in developing new therapies goes beyond awarding contracts and includes offering assistance in designing trials and recruiting test subjects.

The need for such assistance stems in part from a new focus among pharmaceutical companies on drugs for rare diseases or unusual strains of common diseases.

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