By Sandip Shah

Ordinary Americans, reporters, and even a congressional panel heaped scorn on pharmaceutical company Mylan after it raised the price of its epinephrine injector set from $100 to more than $600.

Mylan deserves criticism for making it harder for patients to afford the injectors they need to prevent fatal allergic reactions. But Mylan isn’t the only culprit in this scandal. The FDA is sitting on a huge backlog of generic drug applications. Such bureaucratic lethargy enables companies to form monopolies and gouge consumers.

Policymakers could solve the problem by giving the FDA the mandate and resources to clear this backlog. Instead, they’re training their fire on innovative drug companies that have nothing to do with this price gouging. Their proposed crackdown on these firms wouldn’t stop abusive pricing practices, but it would stifle innovation and deprive patients of lifesaving new medicines.

Price gouging is only possible when companies face no competition. The FDA has created just such a scenario. In October, a full 2,996 generic drug applications were pending approval or review. At least two of those would have offered allergy sufferers an alternative to Epi-Pens.

But the FDA has stalled both applications. The agency complains that one product uses a slightly different design than Epi-Pen, and that the manufacturer of the other product left some testing data out of the application.

This nitpicking is ridiculous. Researchers developed epinephrine in 1901. It’s now off-patent — as are the older, perfectly effective, designs for injectors. The only thing stopping companies from creating an inexpensive, generic epinephrine injector is FDA lollygagging.

Other firms have taken advantage of the agency’s delays. Turing Pharmaceuticals infamously hiked the price of Daraprim, a medicine used to treat AIDS patients, from $13.50 to $750 overnight. The drug hit the market 62 years ago, so its patent expired long ago. Likewise, Valeant Pharmaceuticals increased the prices of the off-patent heart drugs, Isuprel and Nitropress, by 525 percent and 212 percent.

These companies got away with upping their prices so dramatically because they knew the FDA would take years to approve competing products.

When manufacturers introduce generic drugs to the market, prices plummet. The introduction of a second generic drug cuts brand-name drug prices in half, on average.

If policymakers want to prevent price gouging, they simply need to enable the FDA to approve applications far quicker than the current average of 47 months.

Instead of enacting these targeted solutions, many of our leaders are on the warpath against the research firms that spend billions of dollars to create innovative new medicines. They’re calling for all manner of direct and indirect price controls.

Inventing and bringing a new drug to market is a risky and expensive endeavor. It costs about $2.6 billion and takes 10 years.

When a company does strike gold — developing a unique product and gaining FDA approval — restricting competition for a limited time makes sense. Patents give the company a chance to recoup its massive investment in research and development, and ultimately reinvest its profits in developing other new treatments.

Price controls would take away the financial rewards of drug development.
It’s worth paying for truly innovative drugs. But once medicines go off patent, there’s no reason for consumers to continue shelling out top dollar. Speeding the generic drug approval process would introduce competition, slash prices, and prevent rapacious behavior.

Sandip Shah is the founder and president of Market Access Solutions. He spent nearly three decades working at large pharmaceutical firms, where he developed pricing and reimbursement strategies.

By Jeff Stier

EPA officials just discarded the central conclusion of a report they’d been working on for five years to appease green extremists. Although early drafts found no evidence that fracking has had a “widespread, systemic” impact on drinking water, the final report claims there isn’t “enough information to make a broad conclusion.”

How absurd. An honest look at the science should have environmentalists waving the white flag in their fight against fracking. It’s time for the EPA and green crusaders to quit this political charade and recognize that fracking technology has boosted the economy, helped wean America off imported oil and gas, and dramatically reduced CO2 emissions.

In 2015, a draft of the EPA’s report found fracking operations have not “led to widespread, systemic impact on drinking water.” The science in the report hasn’t changed. But the EPA, under pressure, adjusted its conclusion to suit critics to the left of the administration, who would have been left without a leg to stand on in their efforts to sow doubt about fracking safety.

The findings weren’t surprising. EPA Administrator Lisa Jackson conceded she’s “not aware of any proven case where the fracking process itself has affected water.” Energy Secretary Ernest Moniz said he has “not seen any evidence of fracking per se contaminating groundwater.”

Green activists and their Washington allies were quick to contest the draft report, ignoring that EPA researchers relied on more than 950 sources for their report. Do environmentalists really expect us to believe the agency, no friend of the oil and gas industry, is in the pocket of Big Fracking? The academic community is in agreement on fracking; only activists are fracking deniers.

For example, a Duke University study in Arkansas found that shale gas development and hydraulic fracturing had no impact on groundwater.

Scientists analyzing the Marcellus Shale region in Pennsylvania found fracking activity harmless, concluding there was “no evidence for direct communication with shallow drinking water wells due to upward migration from shale horizons.”

This year, a three-year study by the University of Cincinnati found that fracking did not affect water supplies — despite researchers’ best efforts to find a link. Lead scientist Amy Townsend-Small said her team was planning to keep the results under wraps because their funders were hoping the “data could point to a reason to ban” fracking.

Attempts to undermine fracking threaten America’s ability to tap into energy benefits. In 2012, oil and natural gas production saved the average U.S. household at least $1,200. All told, the industry supports almost 10 million jobs and represents 8 percent of the U.S. economy — and those figures are predicted to grow, especially if OPEC keeps its promise to reduce production.

Moreover, fracking has strengthened America’s energy independence. As the world’s leader in oil and natural gas production, the United States can scale back its energy purchases from less-friendly nations.

Despite the green movement’s outrage, fracking is helping the environment. The boom in gas and oil production has enabled us to substitute natural gas for coal. As a result, energy-related carbon dioxide emissions hit their lowest level in nearly three decades.

Environmentalists should stop denying science. Fracking boosts our economy, strengthens energy independence, and protects our environment. It’s a shame that, like the most extreme green activists, the EPA is only willing to embrace science when it serves an anti-fossil-fuel agenda.

Jeff Stier is a senior fellow at the National Center for Public Policy Research in Washington, D.C., and heads its Risk Analysis Division.