U.S. Rep. Fred Upton is employing two unusual strategies in his new “21st Century Cures” initiative. First, he’s making his effort to reform the cumbersome and expensive federal drug approval process a bipartisan operation, teaming with Rep. Diana DeGette of Colorado, one of the ranking Democrats on the House Energy and Commerce Committee that Upton chairs. Second, instead of rushing out a finished piece of legislation, he’s taking the time to listen first — not just to pharmaceutical companies and regulators, but to scientists, doctors and patients as well.

Upton, R-St. Joseph, has been talking informally about the initiative for months and held the first hearing on the subject May 6. The initiative is intended to address some basic and serious concerns: the great time and expense it takes to get a new drug to market and the declining number of new drugs and therapies approved by the U.S. Food and Drug Administration.

Upton likes to say that the drug approval process, largely implemented in the mid-1960s, is stuck in the “Sgt. Pepper era,” when people lined up at record stores to buy new music instead of downloading it to their iPods. We don’t believe the mere fact that the rules are old make them inadequate, but so much has changed in the past 50 years in terms of understanding genetics and molecular biology that it’s worth re-examining the scientific and medical assumptions on which those rules were based.

Medical science can produce marvels, but when it takes 10 years and a billion dollars to get a new drug approved, the benefits of new cures aren’t being brought to bear very quickly. One of Upton’s priorities is exploring how the drug-approval system can be expedited without sacrificing safety. Last month, the FDA gave early approval to a new late-stage cancer drug because it showed such great effectiveness in trials, but Upton notes that such accelerated determinations are rare. In a meeting with The Sentinel’s editorial board, the congressman said he wanted to see if the average research-to-approval period could be reduced from 10 to six years.

Upton has outlined several other goals:

• Encouraging “personalized medicine” by better applying knowledge of the human genome, scarcely understood when the current approval process was put in place.

• Harnessing the power of social media and computer networks to broaden and speed clinical trials.

• Helping the FDA modify its “risk culture.” Upton maintains the scientific and social tools exist to maintain safety while more rapidly approving innovative treatments.

• Fostering better partnerships between the government, drug companies, scientists, doctors and patients.

Upton is well-positioned to advance the initiative. He has another full term ahead of him as chairman of the Energy and Commerce Committee after this year and he enjoys the support of leaders of both parties in the House. Importantly, he is one of the few members of Congress with the experience and inclination to work across the aisle with members of the opposing party.

Talking about clinical trials and testing protocols can all sound very bureaucratic, but this initiative comes down to something very basic and very personal — saving lives. That’s a goal everyone in Washington and around the country should be able to get behind.

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