The following op-ed, co-authored by Pew’s senior director of health programs Allan Coukell and venture capitalist Jonathan Leff, was published in The Wall Street Journal. The authors advocates for legislation that would create a new approval pathway for urgently needed antibiotics.
Existing antibiotics underpin much of modern medicine but are rapidly losing their ability to treat many deadly infections, according to the Centers for Disease Control and Prevention. Yet even as more strains of drug-resistant bacteria emerge, the introduction of new antibiotics has slowed down. Congress should enact a proposed new regulatory pathway that will help spur the investment that can bring new lifesaving treatments to the public.
The need is apparent. The CDC has estimated that each year at least two million Americans contract infections that are resistant to antibiotics—and each year at least 23,000 Americans die as a result.
Consider CRE (Carbapenem-resistant Enterobacteriaceae), a bacteria that resists nearly every available antibiotic, and which the CDC calls an “urgent threat.” CRE was first reported in North Carolina in 2001—and as of this year 48 states have reported infections. The most recent deadly outbreak exposed 179 patients in California hospitals. While only two patients died in the California outbreak, CRE can kill up to 50% of patients when it infects the bloodstream.
In the 1980s, 29 new antibiotics were approved; another 23 were approved during the 1990s. But only nine new drugs made it to market from 2000-10, and a study by the Pew Charitable Trusts shows few drugs in development for the most serious microbial threats such as multidrug resistant Acinetobacter and Pseudomonas aeruginosa.
As bacteria emerge that are resistant to existing classes of antibiotics, new drugs to combat them have become increasingly difficult to discover in nature or design in the lab. And due to long and expensive development paths, as well as limited revenue potential, such drugs are too often not attractive investment opportunities.
To revitalize the search for lifesaving antibiotics, the Food and Drug Administration needs a new way to approve them. Legislation proposed in both the House and the Senate would create a new regulatory pathway that would enable the FDA to approve drugs specifically for patients whose serious infections can’t be treated with existing drugs, and for whom there are few or no other treatment options.
For these patients, the FDA would be empowered to approve new drugs based on fewer or smaller clinical studies than for antibiotics intended for broader use. The goal is to reduce the cost of development and accelerate the availability of new drugs for a targeted public health need.
This idea has attracted bipartisan support. In the Senate, Orrin Hatch (R., Utah) and Michael Bennet (D., Colo.) have introduced the Promise for Antibiotics and Therapeutics for Health (PATH) Act. In the House, John Shimkus (R., Ill.) and Gene Green (D., Texas) put forth similar legislation, the Antibiotic Development to Advance Patient Treatment (Adapt) Act. The House bill was overwhelmingly approved by the Energy and Commerce committee in May as part of a larger bill, the “21st Century Cures” initiative. In the Senate, PATH is pending in committee. The bills (which are essentially the same) have the support of public-health groups, health-care providers and patients.
FDA officials in April testified before the House that the legislation would enhance the agency’s ability to get critical new medicines to patients. The new pathway would also make it more attractive for venture capitalists and innovative pharmaceutical companies to invest the enormous talent and financial resources that antibiotic development requires.
Along with immediately creating this new pathway for antibiotics, the PATH and Adapt Acts would authorize the FDA to use the targeted pathway in other areas of major unmet medical need. The agency, of course, would need to carefully assess when and how that pathway could be applied beyond antibiotics.
Public-health officials across the globe agree that the danger of antibiotic resistance is significant and growing. Targeted pathways for antibiotic approvals are one tool we can deploy in the fight. Congress can and should pass the legislation to support this innovation, which is urgently needed.
Mr. Leff is a partner at Deerfield Management, an investment-management firm. Mr. Coukell is the senior director of health programs at the Pew Charitable Trusts.