[Ip-health] Generating Antibiotic Incentives Now: GAIN -- Or Just Greed

Outterson, Kevin mko at bu.edu
Wed Jun 13 13:41:06 PDT 2012

My own take on GAIN:

Outterson K. All Pain, No GAIN: Need for Prudent Antimicrobial Use Provisions to Complement the GAIN Act. Alliance for the Prudent Use of Antibiotics Clinical Newsletter. 2012;30(1):xxx. http://www.tufts.edu/med/apua/news/news-newsletter-vol-30-no-1-4.shtml

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]) …

… 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…

…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 [10].

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.

Kevin Outterson
Associate Professor
BU Law <http://www.bu.edu/law/faculty/profiles/#o> & BU SPH
Editor in Chief, Journal of Law, Medicine & Ethics <http://www.aslme.org/Publications>
Faculty Associate, Harvard Center for Communicable Disease Dynamics <http://ccdd.hsph.harvard.edu/about/Faculty-Outside-Harvard/Michael-Outterson>
Blogging health law at The Incidental Economist <http://www.theincidentaleconomist.com/>
Research papers at SSRN <http://ssrn.com/author=340746>
mko at bu.edu
617 353 3103 w
Twitter @koutterson

On 6/13/12 10:49 AM, "Burcu Kilic" <bkilic at citizen.org<mailto:bkilic at citizen.org>> wrote:

Generating Antibiotic Incentives Now: GAIN -- Or Just Greed
By: Robert Weissman

Co-authored by Anthony So, professor of the practice of public policy and global health, director, program on global health and technology access at Duke University

The World Health Organization's Director-General recently warned of the growing challenge of antibiotic resistance in the starkest terms: "A post-antibiotic era means, in effect, an end to modern medicine as we know it. Things as common as strep throat or a child's scratched knee could once again kill." In the case of tuberculosis, many infections are already resistant to first-line therapy, and second-line therapy costs between 50 and 200 times more. For methicillin-resistant Staphylococcus aureus (MRSA), an antibiotic-resistant infection that claims more lives than AIDS in the U.S. each year, the costs of these infections to hospitals may reach as high as $4 billion annually.

Responding to this challenge, existing antibiotics must be conserved and novel antibiotics developed. To preserve the effectiveness of antibiotics for human use, Europe banned feeding antibiotics to livestock for growth promotion in 2006. In Denmark, where such use of antibiotics had been phased out more than a decade ago, drug-resistant pathogens in livestock are down while industry output is up. Yet a bill to restrict such use here - The Preservation of Antibiotics for Medical Treatment Act - languishes in the U.S. Congress.

Instead, the Generating Antibiotic Incentives Now, or GAIN, Act has piggybacked into the FDA bill reauthorizing user fees for drug approval. 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.

Resistance to an antibiotic increases as the drug is used more frequently, so the use of new antibiotics must be reserved for resistant infections. However, monopoly protections conflict with the need for preservation by encouraging companies to sell as much of the new drug as possible. Further, this incentive does little to defray the upfront costs of R&D but risks imposing a heavy cost on consumers, both here and abroad. Rationing antibiotics by monopoly pricing will not ensure appropriate use by doctors or patients. 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. Consider the lessons from Abbott's hold over ritonavir, a drug that boosts the effectiveness of other HIV drugs used in combination. In 2003, Abbott hiked the price of ritonavir by 400 percent - except when used for its own combination product, Kaletra - placing other combination treatments relying on this booster drug at a market disadvantage. So does this incentive approach lead to GAIN - or just greed?

Worse yet, the bill fails to address the serious scientific bottlenecks in the pipeline. The customary approaches to identify novel drug candidates have produced dismal results. The experience of a leading drug company suggests that it would take 80 times the number of screens of potential drug compounds to yield one antibiotic launch compared to one drug launch in other therapeutic areas. Throwing just any incentives at antibiotic R&D is not going to work. The solution to the faltering antibiotic pipeline is not an extra dose of data exclusivity.

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.

In these austere economic times, where might such monies come? Leading all sectors in defrauding the federal government under the False Claims Act, the pharmaceutical industry has paid $23 billion in settlements and fines to federal and state governments over the past two decades, some portion of which might have been directed to a foundation that would support innovation and access to such life-saving medicines.

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.

Burcu Kilic, Ph.D.
Legal Counsel, Global Access to Medicines Program
Public Citizen | Protecting Health, Safety and Democracy
TEL: +1 202-588-7792
1600 20th St NW, Washington, DC 20009
URL: http://www.citizen.org/access
Twitter: @burcuno

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