After months of meetings and Congressional hearings on the unrelenting opioid addiction crisis, Congress has finally responded, with 25 bills that aim to attack the problem from all sides. The House Energy and Commerce Committee began two days of hearings on Wednesday that reviewed the draft legislation that lawmakers want to get to the House floor this spring. And a top executive from the biotech industry group BIO was one of several witnesses voicing support for some of the bills today.
Most of the draft legislation centers on improving addiction treatment, prevention, prescription drug monitoring programs, and surveillance and interdiction of illicit opioids. Congressional members largely focused their questions on details of the various bills, but Rep. Jerry McNerny of California asked about the elephant in the room: Would building a border wall or using the death penalty for drug traffickers, as has been proposed recently by President Trump, combat the nation’s opioid problem? FDA Commissioner Scott Gottlieb and acting CDC Director Anne Schuchat hesitated and dodged the loaded question, saying that they wanted to focus on what’s in their purview: intercepting illicit opioids at international mail facilities and collecting data on the importation of these drugs.
Cartier Esham, BIO’s executive vice president for emerging companies, was one of seven witnesses at the hearing today and she discussed three bills that she said are needed to promote R&D for new pain and addiction drugs.
Esham cited a BIO report released last month that highlighted just how thin the pipeline is for these drugs, and how little investment there is: Companies working on pain therapies have received 17 times less funding than those working on cancer drugs. (Check out this article for more on the unique R&D challenges faced by pain drug developers.)
One of the bills BIO supports would spur the FDA to outline how it would speed up the approval of new addiction and safer pain drugs. Another would ask the FDA to explain to industry what clinical data are needed to show that a new therapy reduces opioid use and pain. And the third would give the National Institutes of Health greater authority to fund research and partner with industry in response to public health threats such as the opioid crisis.
Esham also called on the FDA and NIH to figure out ways to improve clinical trial design and boost basic research on pain. “These actions would encourage R&D and investment in medicines that will change the paradigm of how we treat pain and addiction,” said Esham in her testimony.
Esham spoke about other ways to spur on pain drug development. She also added that insurance coverage decisions will also need to be re-examined so that patients can have better access to non-opioid alternatives and not just the low-cost opioids. “Most of our companies are small and rely on venture capital,” said Esham. “If the therapies they’re developing won’t get covered, they won’t get strong investment in those areas.”
The NIH, FDA, the trade group PhRMA and more than 30 drug companies have already been working on some of the technical issues of pain and addiction drug development over the past year in a series of meetings aimed at hammering out a new public private partnership. Their goal is to speed up the development of new pain and addiction drugs by setting up a clinical trials network, sharing data, and working on better biomarkers for pain.
But NIH Director Francis Collins, one of the leaders of this initiative, said in a separate briefing this week that none of these companies have officially signed on to the project or have put in any money of their own, according to S&P Global News. The partnership is basically waiting for government funding to come through. Stephen Ubl, PhRMA’s president and CEO has said that industry would follow through with its commitment once that happens, S&P reports.
Congressional members were busy today, with some also working on a massive spending bill, which includes $500 million for the NIH for the opioid epidemic, and needs to be passed this week to avoid another government shutdown, according to CNBC.
Collins recently told WebMD that he was encouraged by the promises of funding. “Rest assured that we know exactly how those dollars could be spent on the most pressing research needs, after all the planning we have done over the last year.”
