FDA overhaul a rare display of bipartisanship in Congress

June 4, 2012

By: Allison Sherry

WASHINGTON — Twelve companies may have violated the Safe Drinking Water Act when using diesel fuel to extract oil and gas in 19 states, including Colorado, House Democrats charged Monday.

The measure is not some temporary thing or a post office naming, but something meant to help people. Both Republicans and Democrats support it and it should land on the president's desk for signature before July 4.

"By the standards of this place, there has been virtually no partisanship in this at all," said Sen. Michael Bennet, a Democrat who has been shepherding the FDA overhaul through the Senate since 2010. It passed the U.S. Senate 96 to 1. "And my question is why can't we do more of this?"

The FDA overhaul will dramatically change the way the agency operates.

It should assuage the critical drug shortage problem that has hospitals and patients across the country screaming mad. It makes it easier and quicker for drug companies developing promising treatments to get to sick people. And it makes drugs safer overall by requiring more foreign inspections of drug manufacturers. More than 80 percent of all the chemicals used in pharmaceuticals come from abroad.

On the Senate floor, Bennet read a letter from a Longmont woman, Dawn Gibbs, beseeching Congress to help solve the critical drug shortage problem that has affected emergency room and cancer doctors across the country.

Gibbs' 2-year-old cousin has a common form of leukemia. Her doctors told the family they were running dangerously low on her chemotherapy treatment. The child's parents asked the whole family to reach out to various members of Congress to ask them to do something.

"I was happy to do anything that could help her, but in the back of my mind I was thinking this is not going to go anywhere," Gibbs said. "I wrote the letter and I sent it and I thought here goes nothing ... When I heard this was pursued, I thought, 'Guess what! This really worked!' It was a blessing to be able to do something and feel like something was solved."

The bill requires drug companies to communicate when there may be a pending shortage so doctors can adjust treatments accordingly.

Rep. Diana DeGette, D-Denver, first introduced a drug shortage bill last year, but squeezed it into the FDA reauthorization after working with Republicans at the helm of her Energy and Commerce committee.

"It's tremendously satisfying as a legislator, especially a legislator in the minority party," she said. "I think it's worth stopping for a moment and say sometimes something good happens. I'm happy because I'm able to achieve something for my constituents and I think that is a celebration."

Beyond drug shortages, the FDA reauthorization aims to make drug imports safer by requiring U.S. regulators to inspect drug manufacturers abroad. The bill gets rid of an old requirement that U.S. facilities are inspected every two years and instead focuses regulatory inspections on pharmaceutical companies in India and China.

Rep. Cory Gardner, R-Yuma, who also worked on this bill on the Energy and Commerce committee said the bipartisanship was satisfying but said he felt sheepish about being self-congratulatory.

The bill passed the House 387 to 5.

"When Congress does its job, you shouldn't be doing a celebration in the end zone," he said. "It's pretty sad when you're spiking the football when you're doing what you're supposed to do."