WASHINGTON — Government incentives probably will be necessary to rejuvenate the drug development pipeline for antibiotics, Dr. Janet Woodcock, chief medical officer of the Food and Drug Administration, testified before a congressional committee on June 9.
The number of investigational new drug applications for antibiotics has declined since 1987 but has started to increase again over the last 3 years, Dr. Woodcock told the House Energy and Commerce Committee, Subcommittee on Health. But as more bacteria develop resistance to antibiotics, more and new therapies are necessary, she added.
Drug-resistant infections cost $35 billion a year in the United States, yet many companies do not find antibiotics a financially viable product since they involve a limited course of treatment and have generic competition, among other factors.
There also is confusion among the scientific pathway for approval. Dr. Woodcock said that new guidance documents on clinical trial designs are in the works but acknowledged that they may not be enough to push the industry to increase drug development.
“It will likely also take the development of incentives in order to stimulate the development of new antibacterial drugs so that we have new therapeutic options” to treat current and future resistant pathogens, Dr. Woodcock said in written testimony.
Recognizing that government intervention is necessary to help solve the problem is a giant step forward, said Dr. Barry Eisenstein, senior vice president of scientific affairs at Cubist Pharmaceuticals, who also testified at the hearing.
Cubist currently markets daptomycin (Cubicin) for the treatment of skin and skin structure infections caused by certain susceptible strains of Gram-positive microorganisms, including methicillin-resistant Staphylococcus aureus. The company currently has three antibiotic drugs in development, he said.
“To me, this is almost a breakthrough to see a branch of government actually saying, ‘You know what? We really do have market failure, we need government intervention in a meaningful way,’ ” Dr. Eisenstein said in an interview.
In his testimony, Dr. Eisenstein supported policies for antibiotics modeled on the programs that have sparked development of drugs for rare diseases and expanded the knowledge about pediatric uses.
“New incentives must be designed so that they encourage investment in activities across the research spectrum, from basic research to clinical trials, and target as broad a range of scientists, entrepreneurs, large and small companies, and life science investors as possible,” Dr. Eisenstein said in written testimony.
Dr. Woodcock warned that incentives still have to be considered in the context of restrictions that may be required once the drugs are on the market because the ultimate goal is limiting antibiotic use.
“If we contemplated a pipeline that would end up [where] antimicrobials would only be used in niche situations, where they were really needed, that would be even a further disincentive,” she said. "But you have to think about that as a goal to preserve the effect of that for a long time.”
Robin Robinson, Ph.D., director of the Department of Health and Human Services’ Biomedical Advanced Research and Development Authority, said that industry has indicated in the past that liability protections would be very helpful and important in moving drugs along the pipeline.
Dr. Robinson and Dr. Woodcock also said that easing antitrust laws in certain cases to encourage companies to work together was worth exploring. Dr. Robinson noted that BARDA used that the authority in the development of the H5N1 and H1N1 influenza vaccines and certainly could try it again.
“I have worked in public-private partnerships where we have gotten companies together to advance general societal goals and they’ve had to be extremely lawyer-intensive on the antitrust issue,” Dr. Woodcock said. “So there’s no doubt I think it’s a barrier to working together to advance broader goals.”
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