IDSA urges federal measures to spur antibiotic development

To avert a looming public health crisis with a unique set of underlying causes, Congress and the Administration, including federal public health agencies, must act quickly to reinvigorate pharmaceutical investment in antibiotic research and development (R&D). Otherwise, doctors won’t have drugs to protect Americans against antibiotic-resistant infections — a rapidly growing and often-deadly problem. That is the key message of a recent report by the Infectious Diseases Society of America (IDSA). The IDSA recently presented its findings and recommendations to Congress and federal policy-makers.

While the number of drug-resistant infections continues to rise, the number of new antibiotics in the pipeline to treat these infections is drastically declining. Major pharmaceutical companies have abandoned or drastically cut back their antibiotic development efforts because of the unique challenges to making antibiotics profitable. For example, antibiotics produce a weak return on investment for manufacturers because they work so well and fast. Highlights of proposed policy and administrative actions in the report include the following:

  • Establish an independent Commission to Prioritize Antimicrobial Discovery. This commission would decide which infectious pathogens to target using legislative incentives and administrative solutions.
  • Create a new type of "wild-card" patent extension. A company that develops and receives approval for a priority antibiotic could extend the market exclusivity period of another FDA-approved drug as long as the company commits to invest a portion of the profits derived during the extension period back into antibiotic R&D.
  • Provide tax incentives for R&D of priority antibiotics.
  • Establish measured liability protections similar to those that exist for childhood vaccines.

Copies of the report Bad Bugs, No Drugs: As Antibiotic Discovery Stagnates A Public Health Crisis Brews can be accessed and downloaded from the IDSA home page (www.idsociety.org).

NIH to make federally funded research public

Researchers financed with government money soon will be required to provide the National Institutes of Health copies of all final version manuscripts upon acceptance for publication in scientific or medical journals.

NIH will make the manuscripts available six months after publication (or sooner if the publisher agrees) on PubMed Central (PMC), the institute’s digital repository for biomedical research.

Manuscripts are defined as the author’s version following modifications resulting from the peer-review process, a statement from the NIH said. That proposal applies to research funded in whole or in part by the NIH. Specifically, it would include all research grants, cooperative agreements, contracts, and as well as National Research Service Award fellowships.

Since it’s a proposed policy change, the NIH will accept comments for 60 days. Comments should be directed to the NIH web site: http://grants1.nih.gov/index.htm or to publicaccess@nih.gov.

The full proposal can be viewed on the Federal Register or the NIH web site at www.nih.gov.