This is an archived article that was published on sltrib.com in 2016, and information in the article may be outdated. It is provided only for personal research purposes and may not be reprinted.

The idiom "slow and steady wins the race" has many positive applications, but the Food and Drug Administration's (FDA) drug approval process is not one of them. Its arduous process results in fewer products in the U.S. market, higher prices and ultimately less lives saved. This is why I could not be more pleased to see the 21st Century Cures Act pass Congress, which will streamline the drug approval process and also boost biomedical research.

The recent controversy over EpiPen's high price is a perfect illustration of why this bill is so desperately needed. Basic economics teaches that competition drives down prices, but EpiPen's manufacturer, Mylan, has been able to set its prices free from any significant competition. EpiPen first entered the U.S. market in 1987 and yet in 29 years no viable competitor has made it to market.

Teva Pharmaceuticals, a company with a presence in Utah's 2nd Congressional District, has been working hard for years to bring a promising generic epinephrine auto-injector to market to compete with Mylan Pharmaceutical's EpiPen, but the FDA has yet to approve their lower-cost alternative. One reason may be the caps — Mylan has argued that Teva's removable cap is inferior to its own flip-style cap and would affect individuals' ability to properly use Teva's device. This is ridiculous and an example of anti-competitive behavior at its worst. The FDA should be concerned with effectively getting safe products in patients' hands — not stylistic preferences.

In September, I sent a letter to FDA Commissioner Robert Califf stating that the FDA should help incentivize competition for EpiPen by streamlining the approval process for safety-proven generic drugs. Perhaps the recent negative attention has finally pressured the FDA to get the cogs moving where epinephrine auto-injectors are concerned, as I am happy to report that the agency is finally working with Teva on a path forward for their generic EpiPen. But of course it shouldn't take a slew of bad publicity to force the agency to do the right thing.

Unfortunately, it doesn't stop with EpiPen. There is a problem of systemic sluggishness at the FDA. As of July 1, the FDA had 4,036 applications for generic drugs awaiting approval and the average time for approval was 47 months. Personally I find this hard to swallow – no pun intended.

And the FDA's lack of efficiency runs deeper than a backlog of generics. Consider treatment for Duchenne Muscular Dystrophy (DMD), a genetic disorder that predominately affects boys and results in muscle degeneration and ultimately organ failure in their early 20s. For a child with DMD, time is everything, and while I am thrilled to see that the FDA finally approved treatment for DMD after years of consideration, months of stalling and extraordinary public pressure — including from Congress — it was sadly too late for many boys and their families.

FDA clinical trials results showed that 10 out of 12 boys could still walk after treatment for DMD compared to only one out of 11 in the control group. Despite such promising results, the treatment became stuck in the bureaucratic morass of the FDA. One reason given for not approving the treatment sooner was that perhaps the study was not valid because the boys in the group with positive results may have had more motivated moms. Although this may be true, it is by no means a reason to prevent a promising and safety-proven therapy from entering the market. When lives hang in the balance and potential treatments exist, "slow and steady" does not win the race.

Ultimately, I proudly voted in favor of the 21st Century Cures Act because it puts the patient first by bring meaningful reform to the FDA and incentivizing biomedical innovation.

Rep. Chris Stewart represents Utah's 2nd Congressional District.