Gottlieb and Kleinke: There’s a Medical App for That—Or Not – WSJ.com

Even the most ideologically opposed politicians agree: Health care is choking on paperwork, and medicine is prone to errors of handwriting, lost information and guesswork. That’s why the promotion of health information technology is one of the only demilitarized zones in Washington—consistently attracting bipartisan support since the Bush administration began funding ways to standardize and computerize health-care records a decade ago.

Despite such broad political support—plus that of health insurers, providers, drug companies and patient groups—the Food and Drug Administration (FDA) unfortunately has rushed in to play bureaucratic spoiler just as this new engine of innovation was leaving the station.

via Gottlieb and Kleinke: There’s a Medical App for That—Or Not – WSJ.com.

How entrepreneurs are leading the fight against fake pharmaceuticals – Health – AEI

Like holograms, original track and trace technologies also help companies monitor the supply chain. Start-ups like Sproxil in Nigeria, mPedigree in Ghana, and Pharmasecure in India provide companies with bar codes or scratch pads that reveal a unique tracking number. The consumer then texts that number to the company providing the service to learn if his or her medicine is the real thing. India has now mandated that from next year on all exported products will require track and trace authentication systems, no doubt much of it provided by Pharmasecure.

Yet even with these technologies, dangerous products are still prevalent around the world and continue to slip into the U.S. But with the help of entrepreneurs, new solutions are likely to be developed so that dangerous medicines become a rare and tragic occurrence, rather than an ever-present threat.

via How entrepreneurs are leading the fight against fake pharmaceuticals – Health – AEI.

Access Delayed, Access Denied: Waiting for New Medicines in Canada 2011 by Mark Rovere, Brett Skinner :: SSRN

Federal and provincial government policies create unnecessary delays for patients wanting access to new drug treatments. The federal government does not allow patients to use new drugs until Health Canada has reviewed each product’s safety and effectiveness information. The latest data show that in 2009 Health Canada took 472 days on average to approve new drugs, up from 388 days in 2008. Health Canada took longer to approve new drugs than regulators in Europe in all four years studied (2006 to 2009) and longer than the American FDA in five of the last six years studied (2004 to 2009). Relative to other countries, Canadian patients wait too long for government permission to use new drug treatments.

via Access Delayed, Access Denied: Waiting for New Medicines in Canada 2011 by Mark Rovere, Brett Skinner :: SSRN.

The wrong way to stop fake drugs – Health – AEI

the answer is not to outlaw this business entirely. Foreign versions of drugs can cost roughly half what they do in the United States. For the millions of Americans who are uninsured or underinsured, buying from international, credentialed online pharmacies could provide access to the medicines they need at a price they can afford. The online market for drugs is already substantial, with probably more than a million Americans regularly participating. But it is growing slowly because of concern about drug safety and, of course, legality. While the F.D.A. does not prosecute individual consumers whose purchases present no threat to themselves or the public and grants some waivers to those buying less than three months’ supply of a drug from abroad, most are still technically considered criminals.

via The wrong way to stop fake drugs – Health – AEI.

The Ethics of Postmarketing Observational Studies of Drug Safety Under Section 505(o)(3) of the Food, Drug, and Cosmetic Act by Barbara Evans :: SSRN

In 2007, Congress granted the Food and Drug Administration (FDA) new powers to order pharmaceutical companies to conduct drug safety studies and clinical trials in the postmarketing period after drugs are approved. The FDA envisions that these studies will include observational studies that examine patients’ preexisting insurance claims data and clinical records to infer whether drugs are safe in actual clinical practice. While these studies offer a valuable tool for improving drug safety, they raise troubling ethical and privacy issues because they imply widespread use of patients’ health information in commercial research by drug manufacturers. This is the first article to explore the ethics of these sec. 505(o)(3) observational studies, so named after the section of the Food, Drug, and Cosmetic Act that authorizes them.

Data access problems threaten to make the FDA’s sec. 505(o)(3) study requirements unenforceable. Under existing federal privacy regulations, it appears highly unlikely that pharmaceutical companies will have reliable access to crucial data resources, such as insurance claims data and healthcare records, to use in these studies. If pharmaceutical companies do manage to gain access to the needed data, this will raise serious privacy concerns because sec. 505(o)(3) observational studies do not appear to be covered by any of the major federal regulations that afford ethical and privacy protections to persons whose data are used in research.

If the FDA’s program of sec. 505(o)(3) observational studies fails because of the above problems, this failure will have a number of bad consequences: the public will be exposed to avoidable drug safety risks; taxpayers may be forced to bear the costs of having the FDA conduct drug safety investigations that would have been funded by drug manufacturers if data had been available; and, perhaps most troubling, the FDA may be forced to order postmarketing clinical trials to answer questions that could have been answered using observational studies. Problems with access to data for sec. 505(o)(3) studies thus could directly imperil human research subjects by forcing a needless over-reliance on risky postmarketing drug safety trials.

The article concludes by describing a promising new legal pathway for resolving these problems. Congress has provided the FDA a new set of powers that if skillfully exercised will allow the agency: (1) to facilitate pharmaceutical companies’ appropriate access to data for use in sec. 505(o)(3) observational studies, (2) to impose strict ethical and privacy protections for persons whose data are used in these studies, and (3) to mobilize private-sector funding to generate much-needed evidence of the safety of FDA-approved drugs.

via The Ethics of Postmarketing Observational Studies of Drug Safety Under Section 505(o)(3) of the Food, Drug, and Cosmetic Act by Barbara Evans :: SSRN.

The Stay Dilemma: Examining Brand and Generic Incentives for Delaying the Resolution of Pharmaceutical Patent Litigation by Michael Herman :: SSRN

The Hatch-Waxman Act encourages generic drug companies to challenge the patents on brand name drugs by awarding the first generic challenger 180 days of generic marketing exclusivity, a bounty often worth millions of dollars. Challenging a patent usually triggers patent infringement litigation from the brand name firm. In response to the increased numbers of patent challenges, brand name firms have adopted an “evergreening” strategy — filing for multiple patents for each drug hoping that the generic firm will not be able to successfully challenge all of the patents and that the continued validity of just one of them will prevent generic entry. Evergreening inevitably results in patents of different strengths. Generics have responded to this strategy by challenging only the weaker patents on a drug and then filing for a stay of the subsequent patent infringement lawsuit until the strong patents are about to expire — which is often many years in the future. Generics seek these stays because an early litigation victory would grant a period of exclusivity that they could not use because the strong patents continue to block generic entry. Brand name firms should also favor stays because by delaying the generic’s exclusivity period, the stay also ultimately delays full competition. Yet in two out of three cases, the brand name firm opposed the stay motion. Courts are split on whether to grant the motions but have not addressed the anticompetitive consequences of stays. This Note explores the cases, regulatory background, and economic incentives surrounding the stays and concludes that stay motions should be denied.

via The Stay Dilemma: Examining Brand and Generic Incentives for Delaying the Resolution of Pharmaceutical Patent Litigation by Michael Herman :: SSRN.

Excerpt from ‘Identity and Invention: The Culture and Ethics of Personalized Medicine Patenting’ by Shubha Ghosh :: SSRN

Personalized medicine has received attention from scholars and policy makers. This book contributes to the literature by focusing on the issues raised by patenting and commercialization in the field of personalized medicine. This excerpt, from a forthcoming book, presents the policy background and discussions of four case studies related to personalized medicine patenting: the Myriad breast cancer gene controversy, the Nitromed patent on a method for treating hypertension in black patients, the personalized medicine project by the Marshfield Clinic, and the pending controversy between Prometheus Labs and the Mayo Clinic before the United States Supreme Court.

via Excerpt from ‘Identity and Invention: The Culture and Ethics of Personalized Medicine Patenting’ by Shubha Ghosh :: SSRN.

Exclusivity Without Patents: The New Frontier of FDA Regulation for Genetic Materials by Gregory Dolin :: SSRN

Over the last twenty years, the legal and scientific academic communities have been embroiled in a debate about patent eligibility of genetic materials. The stakes for both sides couldn’t be higher. On one hand are the potential multi-billion dollar profits on the fruits of research (from newly discovered genes) and on the other is the ability of scientists to continue and expand research into the human genome as well as patients’ access to affordable diagnostic and therapeutic modalities. This debate is currently pending before the Supreme Court which has under consideration petition for certiorari in Ass’n for Molecular Pathology v. USPTO.

This paper recognizes that both sides have legitimate concerns. Given the unique nature of DNA, patents that broadly cover genetic materials and prevent their use (except by the license of the patentee) create insurmountable roadblocks for future research. However, denying exclusive rights to the fruits of laborious and costly research will remove the necessary incentives for investment in these endeavors, thus delaying scientific and medical discoveries.

To remedy these problems, the paper proposes a non-patent exclusivity system administered by the Food & Drug Administration. Under such a system, the innovators who bring new therapeutic or diagnostic products to market will receive exclusive rights to market their products for a limited time. This will provide sufficient market-based incentives to continue with the research and investment in this area. At the same time, because genetic sequences will no longer be broadly protected by patents, the public will be able to access these basic research tools without fear of infringement litigation. This approach addresses concerns of the both sides to the debate, and leads to a cheaper, more predictable, and easier to administer system of exclusive rights.

via Exclusivity Without Patents: The New Frontier of FDA Regulation for Genetic Materials by Gregory Dolin :: SSRN.

White House and F.D.A. at Odds on Regulatory Issues – NYTimes.com

Nancy-Ann DeParle, the whip-smart and sometimes caustic White House deputy chief of staff, picked up The Wall Street Journal one summer day in 2010 and got an unwelcome shock. The Food and Drug Administration was proposing as part of the new health care law to require that movie theaters post calorie counts for popcorn — and this was the first she had heard of it.

via White House and F.D.A. at Odds on Regulatory Issues – NYTimes.com.

Should foreign companies be able to sell drugs directly to Americans? « The Enterprise Blog

It makes sense for these impoverished and sick people to be able to buy cheaper drugs from foreign pharmacies. But if many of uninsured people are simply not taking their medications because they are unaffordable, it is quite possible that drug manufacturers could profit from these sales as well. Of course, the market is likely to remain segmented – with just the uninsured buying from overseas – as long as insurers do not have to provide reimbursement for such purchases.

Data simply don’t exist to measure this accurately, at least as far as I’m aware. But it must be possible to ascertain buying habits of clients of certain web pharmacies via questionnaires. I suspect that, as economic theory suggests, foreign web sellers could prove egalitarian and efficient. This is something I hope to investigate.

via Should foreign companies be able to sell drugs directly to Americans? « The Enterprise Blog.