Conference Coverage
“[Dr. Collins] notes that the NIH’s purchasing power has shrunk by 25% over the last decade and he fears that we are in danger of losing a generation of young scientists who no longer see a future in biomedical research,” he continued. “This is something that we’ve got to correct. And rather than talk about all of the new things we can do for the 21st Century Cures Initiative, before we do any of them, we’ve got to fund NIH. It’s critical that we do that and that the resources be there for the NIH to do its job.”
Expressing pessimism about the likelihood that adequate funding will emerge, Rep. Waxman, who is retiring at the end of this term after representing his district in California for 40 years, cited the recent practices of shutting down the federal government and enacting sequestration of funds as principal reasons why the NIH has been left shortchanged when, instead, Congress should have been putting more money into its budget.
“It will be very important to ensure that the legislative proposals in the 21st Century Cures package strike the kind of balance that was so key to the Orphan Drug Act,” he said. “When they look at the legislation and they’re looking at ways to get these cures out faster, we must not compromise the FDA’s standards for approval, and [the legislation] must be carefully tailored to address and clearly identify problems.”
He pointed to a bill under consideration as part of the Cures Initiative that he says falls far short of these goals. Known as the “MODDERN Cures Act” (“Modernizing Our Drug & Diagnostics Evaluation and Regulatory Network,” HR 3116), the bill, its advocates contend, will encourage pharmaceutical companies to develop “dormant” therapies—drugs that show promise as potential treatments for serious illnesses but are not being pursued because of inadequate patent protection. “On its face, this seems a worthwhile goal,” Rep. Waxman said. “However, the way it proposes to accomplish it is by providing 15 years of exclusivity and 15 years of patent protection after approval for any drug that meets certain limited requirements. As one of our witnesses at the hearing on this bill testified, virtually any drug with a novel active ingredient could qualify for this reward.”
In the view of Rep. Waxman, whom the Nation labeled “the Democrats’ Eliot Ness” for his tenacious Congressional oversight, the bill gives away too much and will interfere with the goal of making drugs affordable. “[One aim] of this MODDERN law is to have the FDA look at all the different ways that it can permit drugs and devices to go on the market, with different thresholds for them to meet,” he commented. “Congress shouldn’t be in this business of dictating the kind of level of evidence needed to permit drugs and devices to go on the market.
“Congress’s job should be to ensure that the FDA has the regulatory authority needed to make use of the latest scientific advances,” he said. “We should create policies that foster scientific advances, but we should not enact regulatory policies based on how far we wish those advances had progressed.”
—Fred Balzac