The Senate is starting to take a look at how to get new drugs, medical devices and treatments for cancer and other diseases to the public faster and with less expense.
Sens. Richard Burr, R-N.C., and Lamar Alexander, R-Tenn., got the effort started with a report Thursday that outlines an investigation of what new policies are needed to improve the work of the National Institutes of Health and the Food and Drug Administration.
“We are in an exciting era of medicine that holds tremendous potential to improve treatments and outcomes for patients,” Burr said in a statement. “But to realize this potential, we must ensure that our nation’s discovery and development processes are working as well as possible.”
He said the work would help medical researchers and companies developing new medical products, many of which are based in North Carolina, where pharmaceuticals is a leading industry.
“This is good for our innovators, it is good for our patients and it is good for North Carolina,” Burr said on the Senate floor.
The White House also is stressing a need for medical advances. On Friday, President Barack Obama called for advancing precision medicine, also known as personalized medicine, which takes into account each person’s genes, environment and lifestyle to treat and prevent diseases.
Obama noted in remarks Friday that when he was a senator in 2005, he and Burr had worked on a bill that supported precision medicine.
The president called for $215 million to help fund the research. The money would include $130 million for NIH to set up a base of 1 million volunteers to provide data for research, and $70 million for the National Cancer Institute to scale up research based on genetics.
Burr has been working on the question of how to get new medicines into the hands of patients faster since he served in the House of Representatives for a decade. Alexander said Thursday that Burr had done more than anyone else in the Senate to think of ways to get treatments, medical devices and drugs through the approval process to people who needed them.
“We want to know what successes we can replicate, and what failures must be learned from and fixed,” they wrote.
One key area will be to look at how the FDA approves medical products. The agency in the past has acknowledged that it must keep up with rapid advances in scientific knowledge in order to review and decide whether to approve new products.
Sen. Patty Murray of Washington, the ranking Democrat on the committee, said her state also had led the way in biomedical innovations. She said she looked forward to working with Burr and Alexander and with members of the House Energy and Commerce Committee who’ve been investigating the same topic.
“I’m very interested in working together to boost federal investments in basic research, find more efficient, effective tools to develop new therapies, continue to enhance flexibility in clinical trials and more,” Murray said in a statement, adding that it also was important to maintain “the highest standards of patient and consumer protection.”
The report from Burr and Alexander warns that the United States might lose its edge in medical research if the FDA’s regulatory process becomes too slow. The report found that venture capital in medical research and development was shrinking in the United States and moving to other parts of the world.
In response to the report, the NIH said in a statement: “Biomedical research funded by the National Institutes of Health (NIH) has been advancing our understanding of health and disease for more than a century; scientific and technological breakthroughs generated by NIH-supported research are behind much of the gains our country has enjoyed in health and longevity.”
The NIH also said that 76 percent of the new drugs approved by Japan, the European Union and the U.S. from 2009 to 2013 were approved first by the FDA, according to a report released in April by the British-based Centre for Innovation in Regulatory Science, and that last year the FDA approved 51 drugs and biological products, the most approvals in nearly 20 years.
The pharmaceutical industry and its employees have contributed to the campaigns of Burr and Alexander. Burr was the top recipient of campaign money from the industry in 2010, his last election. Alexander was in the top 10 last year, as was former Sen. Kay Hagan, D-N.C., who lost her re-election bid, according to the Center for Responsive Politics, a nonpartisan research group that tracks money in politics.