Interesting commentaries on the antibiotic incentives in the pending PDUFA V legislation:
- Politico focuses on the differences between the House and Senate bills:
“The FDA and the pharmaceutical industry are locking horns over how to spur the development of new antibiotics through provisions in the massive user fee law…The disagreement is over how to identify which drugs get that rich reward. The House bill, favored by manufacturers, would grant the extra “market exclusivity” to drugs that treat infections caused by a specific list of nasty bugs. That would largely remove FDA discretion from the equation. The Senate bill, on the other hand, puts FDA front and center, requiring the agency to identify a new antibiotic as treating a “serious or life-threatening” condition before the drug qualifies for the benefits.”
Why give incentives to antibiotics that treat non-serious conditions? I’ve previously argued, the Senate bill is better, limiting the incentives to important drugs rather than yet more me-too antibiotics.
- Robert Weissman and Anthony So, writing at HuffPo, criticize the entire effort as misplaced:
GAIN would provide five more years of monopoly protections for new antibiotics. Already receiving three to seven years of exclusivity, some antibiotics may receive up to 10 years of protection after market approval. This measure defies both the economics and biology of antibiotic resistance… monopoly protections conflict with the need for preservation by encouraging companies to sell as much of the new drug as possible… Lengthening the monopoly period will not lead to firms forfeiting today’s profit for preserving tomorrow’s antibiotic effectiveness. In fact, the same drug companies do not even reserve classes of antibiotics important for treating human disease from non-therapeutic use in growth promotion in animals. And there is no profit from drugs kept in reserve.
Multiple drugs used in combination are the mainstay of treatment for diseases like tuberculosis. Yet extended exclusivity may thwart the innovation and access to such combination therapy…
So does this incentive approach lead to GAIN – or just greed?…
We need to get back to the basics – the 3Rs – sharing resources, risks and rewards. Greater public support for new models of R&D collaboration would help share resources and risks with the private sector. Bolstering such efforts, like those at NIH’s National Center for Advancing Translational Sciences, might help lower the barriers to bringing forward new antibiotics to clinical trials. One method of sharing rewards – offering prizes – could enable companies to recuperate their R&D investments without relying just on revenues from the quantity of antibiotics sold…
The failure to find suitable incentives reflects a poverty of policy imagination. The greatest cost, though, may be the complacency that comes with believing that Congress addressed antibiotic resistance with this measure. Even with the GAIN Act’s passage, this public health challenge will still remain: Tomorrow’s infections will not be cured with this expensive placebo.
- My critique of GAIN is now published by the Alliance for the Prudent Use of Antibiotics (APUA) Clinical Newsletter, vol. 30. :
The development of new antibiotics without having mechanisms to insure their appropriate use is much like supplying your alcoholic patients with a finer brandy. (Dennis Maki, IDSA meeting, 1998 [1, 2]) … the current draft of the GAIN Act does not provide any binding requirements to implement antimicrobial stewardship, appropriate use, and conservation. It focuses exclusively on bringing new antibiotics to market quickly, without any changes whatsoever to patterns of use in either human or animal populations. More brandy for the alcoholics….
What has survived is an entirely one-sided emphasis on bringing new antibiotics to market quickly, even if the safety data is less complete and without regard to appropriate use. The GAIN Act will add 5 or more years of data exclusivity on to the end of patent terms for “qualified infectious disease products,” extending the effective patent period by about 40%, from 12 to 17 years. In economic terms, these extensions in effective patent life will eventually cost the U.S. health care system several billion dollars in prescription drug expenses due to the delayed introduction of generic antibiotics. But, in a perfect Washington game, these expenses will not count against the GAIN Act when the Congressional Budget Office scores the bill…
… in early April 2012, several stewardship proposals were made to congressional staff during bipartisan discussions on the GAIN Act. One proposal was to limit the new GAIN incentives to companies that met appropriate use or stewardship targets set by the FDA. In other words, the federal government would agree to spend billions to bring new antibiotics to market, but only if the companies were careful with how they were used. Another proposal called for the Centers for Disease Control and Prevention (CDC) to spend $10 million per year in surveillance, to track the resistance profiles of the new drugs approved under GAIN. Neither proposal made the cut. The only amendment that might be considered friendly to appropriate use is proposed section 906 of the Senate bill, which calls for a study by the National Academies on alternative business models for antimicrobial R&D, including prize funds [4-5].
At this point, public health would be better served if GAIN did not pass as part of PDUFA V. Any new incentives for rushing antibiotics to market must be matched by similar commitments to stewardship and appropriate use [6-7]. Value-based reimbursement of both antibiotics and companion diagnostics should include strong support for appropriate use [8-9]. Otherwise, we might succeed at meeting the IDSA’s goal of 10 new drugs by 2020, but fail in the ultimate goal of having effective antimicrobials at the moment of need due to accelerating resistance .
The correct policy isn’t simply conservation or new production; we need both, in a balanced approach. As currently drafted, GAIN is not balanced, but this could be corrected this summer in the Conference Committee before Congress passes PDUFA V.