Today’s Courier Herald Column:
We all know we have a “do nothing” Congress, because we are told that virtually every day. We also know that there is no agreement on how to fix health care delivery in our country, as each party and Presidential campaign seeks to remind us constantly that the other guys are screwing it up. So it was a bit unusual to receive a press release from Congressman Phil Gingrey announcing the FDA’s designation of a new drug.
Delafloxacin is under development as medication to treat things such as pneumonia, bronchitis, and skin infections. It received special status by the FDA to be considered for fast track approval as provided for under the GAIN Act, which Gingrey authored in 2011 and was signed into law by President Obama this past summer.
GAIN – Generating Antibiotic Incentives Now – was conceived to prime a pipeline of new generation antibiotics. New “superbugs” like MSRA have proven to be resistant to existing drugs. Soldiers in Iraq and Afghanistan are returning home with Acinetobacter baumannii infections which have been proven to be resistant to all known antibiotics, according to Pew Trust’s Health Group.
Pew also cites the resistance of drug makers to develop drugs to treat these conditions, noting that development of a new drug is commonly expected to cost hundreds of millions of dollars, while treatments for infections requiring antibiotics require medication that lasts only a few days. Drug companies, who have exclusive rights to their discoveries for only a limited time before generic drug makers are allowed to copy their creations and compete with the inventors, would much rather focus on drugs that must be taken daily over long periods of time to treat items such as high cholesterol or hypertension, as they have a much higher potential return on investment.
The GAIN act seeks to remedy some of the concerns of the drug makers to get these drugs to market faster while helping those who seek to risk development funds get a return on their investment for finding new solutions. The FDA is now required to grant a priority review to drugs that are intended to fight specific types on infections, which should cut the development time of the drugs and get the successful ones to market faster. In addition, the exclusive rights to market these drugs before generic competition is allowed has been extended for those drugs that make it to market by five years.
Gingrey said in a statement “Fast tracking drugs like delafloxacin will help decrease the risk of a nationwide, drug-resistant epidemic. As a physician for more than 30 years, I understand the critical need for new medical treatments. Because of the GAIN Act, today marks the first step in that direction. I look forward to the research and development of more drug-resistant antibiotics.”
Given the gridlock that surrounds Washington these days, Gingrey appears to have an actual accomplishment on his hands. He identified a real problem, found 3 Republican and 3 Democratic co-sponsors in the House, and managed to craft legislation that passed a Republican House and a Democratic Senate during a time when most news out of Washington reminds us how divided we are as a country.
Mostly under the radar of that fray, Gingrey managed to come up with a solution that successfully blends market realities and government power, build a bi-partisan coalition, and win the signature of our President from another party.
Delafloxacin will likely never be a household name, and in fact may never even make it through the approval process. It’s existence, however, is tangible evidence that as broken as our national government appears when dealing with our complex world, there are still moments that provide a brief glimpse of what is possible when grandstanding gives way to true problem solving.