Congressman Gingrey GAINs A Win

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.


  1. John Konop says:

    I have had the pleasure of talking with Congressman Gingrey numerous times through the years. I do think he has a very good staff, and seeks out information to best represent his constituents as demonstrated here….. A thumps up for Congressman Gingrey!

  2. Scott65 says:

    I hate to rain on this lovefest, but there are some things not being brought up here. First, most of these drugs that are developed are heavily subsidized with grants from the government, so the “out of pocket” from these drug companies are no where near what they want you to believe. Second, these drug companies have been using the public as a big hostage to get the government to pay them to develop these drugs. Third, this bill gives EXISTING drugs covered under patent another 5 years so they can extort people in need. Countries like Canada limit the prices that can be charged for these drugs as do many other countries. We here in the US have to pay sometimes 3x more (to subsidize) yet we cant get them in Canada (I used to do that and saved thousands over a period of a year for exactly the same drug down to packaging) due to the pharma lobby. Generic drugs are a lifeline to lots of people and this makes it harder to get them. As for the drug mentioned it is part of a class called fluoroquinolones. These drugs have already shown to be ineffective for some common infections. If the congressman wants to fight a disease that will soon have no cure…he should be looking at gonorrhea (700,000 cases REPORTED annually), and the last antibiotic known effective is showing resistance in some Asian countries. Delafloxacin is hardly a miracle drug (but will be wildly expensive) and will be effective only briefly as this class of drugs breeds resistance fairly quickly. A 10 fold increase in strength does little if the bug is resistant to it in the first place

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