Amidst all the clamor surrounding today's anticipated Supreme Court decision about the Affordable Care Act, another major piece of health-related legislation received scant attention this week when it passed the House and Senate with strong bipartisan support.
The Federal Drug Administration Safety and Innovation Act of 2012 passed the Senate on a 92-4 vote Tuesday after earlier gainingd easy House approval. The purpose of the act is to help speed to market safe, effective drugs and medical devices, while better controlling fraudulent and dangerous drugs and substances.
Provisions include a mandate that drug manufacturers notify the FDA six months in advance of any plan to discontinue the production of critical drugs. Drug shortages have become a significant problem for hospitals when, for business reasons, manufacturers shift production priorities. Advance notice will lead to better planning and the opportunity to develop new production lines.
The law, expected to be signed by President Obama, also increases penalties for the dispensing of counterfeit drugs. It classifies as controlled substances materials that now fall through the regulatory cracks, such as "bath salts," so labeled to mask their real use, when ingested, to cause a psychedelic reaction, and synthetic marijuana. And it gives FDA greater leeway in regulating the safety of medical devices.
But the most important components are provisions meant to speed up the development of antibiotics. This newspaper has focused before on the critical need to develop new classes of antibiotics to stop infections immune to existing treatment. Particular praise goes to Sen. Richard Blumenthal, D-Conn., who pushed to include antibiotic production incentives in the bill.
Each year 90,000 Americans die from health care-associated infections, many resistant to antibiotics. From 1993 to 2005 hospital stays caused by antibiotic-resistant MRSA infections increased from 1,900 to 368,000, a number that continues to grow.
These bacteria testify to the ability of life, particularly at the microscopic level, to survive by quickly evolving. They develop multiple cell walls to prevent attack, the ability to expel antibiotic molecules, and some generate chemicals to inactivate those molecules.
Producing antibiotics that can stop these deadly "superbugs" would not only save lives, but money. A 2009 study concluded that drug-resistant infections cost the U.S. health care system $26 billion annually, causing 8 million additional days of hospitalization. Another study calculated that these drug-resistant infections boost hospital costs by 29.3 percent, lengthening hospital stays by nearly 24 percent.
Despite this threat, antibiotic development is anemic. From 1935 to 1968, drugmakers developed 13 new classes of antibiotics, but only two new classes have emerged in the last 44 years. Dr. Thomas R. Frieden, director of the Centers for Disease Control and Prevention, warns that if this trend is not reversed the world could enter a post-antibiotic era, when again people die from common infections.
The new law contains provisions intended to revive antibiotic research and development. Because antibiotics are difficult and costly to develop and to test in patients, drug developers need more time to recoup investments. For new antibiotics that treat serious infections, the bill increases from 5 to 10 years the exclusivity from generic competition following FDA approval.
Also discouraging investment in new antibiotic research is the reality that antibiotics are used for short periods, often a few days, meaning less return on investment as compared to hypertension and diabetes drugs that a patient can use for a lifetime. But new antibiotics, if designated as infectious disease products, will now receive priority review and fast-track status from the FDA, another change intended to encourage new investment in research.
Even with these incentives, large pharmaceutical companies may remain reluctant to invest in antibiotics. But Sharon Ladin, director of the Pew Health Group's Antibiotics and Innovation Project, said she sees the potential for small and mid-sized medical research and development companies to fill that research void. States, including Connecticut, should look for opportunities to collaborate with such research firms, given their importance and growth potential.
Enormous challenges remain, but this bill moves policy in the right direction.