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Posts in category FDA

The Power of Sharing: Rethinking the Future of Intellectual Property and Biomedical Research

Apr30
2013 Leave a Comment Written by Aliza Glasner

Recently, the U.S. Supreme Court heard oral arguments in Association for Molecular Pathology v. Myriad Genetics, Case No. 11-725, on the eligibility of patenting the BRCA1 and BRCA2 genes, which identify hereditary breast and ovarian cancers. The Court granted certiorari to hear this case after a split developed among the United States circuit court of appeals in which some courts held that identifying a gene is noveLorenz, Lee. "We're a natural, Rachel. I handle intellectual property, and you're a content-provider." The New Yorker. 19 June 1995. Source: http://www.condenaststore.com/-sp/We-re-a-natural-Rachel-I-handle-intellectual-property-and-you-re-a-co-New-Yorker-Cartoon-Prints_i8541999_.html and therefore subject to U.S. patent laws, while others held that identifying a gene is merely a “law of nature” and therefore cannot be patented. While we wait for the Court to finish deliberating, we must consider the implications of its decision.

Arguments on each side of the Myriad case center on protecting innovation. The U.S. patent system boasts a successful history of protecting large investments in research, which result in innovative products. In the case at hand, Myriad Genetics has invested almost two decades and hundreds of millions of dollars into its research. Supporters of Myriad and the right to patent genes more broadly argue that without these protections locked in place, a company has no incentive to invest in discovery. READ MORE »

Posted in National Healthcare

Lawsuit Offers Hope that the Plan B OTC Age Restrictions may yet be Lifted

Dec31
2011 Leave a Comment Written by Kelli K. Garcia

The fight to make Plan B, an emergency contraceptive, more widely available continues despite Health and Human Services Secretary, Kathleen Sebelius’ decision earlier this month to overrule the FDA’s recommendation that Plan B be made available over-the-counter (OTC) to women and girls of all ages. The Center for Reproductive Rights (CRR) will reopen a lawsuit, Tummino v. Hamburg, originally filed in 2005 in response to the FDA’s denial of a citizen’s petition to make Plan B available OTC to women of all ages. According to the complaint filed by CRR at the time the FDA’s decision was “not supported by medical or scientific evidence.”

The battle over OTC access to Plan B has been contentious. In 2003, the FDA rejected an application to make Plan B available OTC, citing a lack of data on women under 16. In 2005, two FDA officials, Susan Wood and Frank Davidoff, resigned after the FDA announced that it was going to postpone the approval of OTC Plan B indefinitely. Finally, in 2006 and several rejections later, the FDA approved OTC Plan B but only for women 18 and older. In 2009, U.S. District Court Judge Edward Korman, ordered the FDA to allow OTC sales of Plan B for women 17 and older and urged that the FDA lift any age restrictions. According to Korman, the FDA’s decisions regarding Plan B were, “arbitrary and capricious because they were not the result of reasoned and good faith decision-making.” In addition, Judge Korman ordered the FDA to rule on the citizen’s petition with regards to OTC Plan B for women and girls under the age of 17. READ MORE »

Posted in National Healthcare, Uncategorized - Tagged ,

Judge invites challenge to HHS decision that blocked access to emergency contraception

Dec16
2011 Leave a Comment Written by O’Neill Institute

Originally posted at Hunter of Justice on December 14, 2011.

The Center for Reproductive Rights announced Tuesday that it will reopen a lawsuit filed in 2005 in order to challenge unnecessary age restrictions on emergency contraceptives imposed last week by the Obama administration. The lawsuit – Tummino v. von Hamburg –  was originally filed against the FDA. At a hearing on Tuesday, U.S. District Judge Edward Korman invited the Center to refile and expand the case in order to contest the action by U.S. Department of Health and Human Services (HHS) Secretary Kathleen Sebelius overruling the FDA’s recent approval of “Plan B” contraceptives.  READ MORE »

Posted in National Healthcare - Tagged

Court Enjoins FDA Tobacco Labels

Nov22
2011 Leave a Comment Written by O’Neill Institute

This post was authored by O’Neill Institute research assistant and third-year Georgetown University Law Center student Mirona Dragnea.

Proposed New Warning Label by FDA

On November 7, 2011, District Judge Richard J. Leon of the D.C. District Court sided with five tobacco companies in granting a preliminary injunction in R.J. Reynolds v. U.S. FDA. The decision prohibits the United States Food and Drug Administration (“FDA”) from enforcing its rules requiring new graphic labels on cigarette packages. 

The Family Smoking Prevention and Tobacco Control Act was signed into law by President Obama on June 22, 2009, and gives FDA the authority to regulate the manufacture and sale of tobacco products. As part of this Act, in June 2011, FDA published a final rule, which requires, among other things, that all cigarette packages manufactured and distributed in the United States after September 22, 2012 display cigarette warning labels. These warning labels are comprised of nine rotating textual warnings accompanied by graphic images, and must cover the top 50% of both the front and back panels of all cigarette packages. READ MORE »

Posted in National Healthcare, Tobacco, Uncategorized - Tagged , , ,

What Does It Mean to Inform?

Aug01
2011 Leave a Comment Written by O’Neill Institute

This post was authored by Sam Halabi, J.D., M.Phil., Assistant Professor, University of Tulsa College of Law.

What Does it Mean to Inform?

In response to the graphic warnings released by the U.S. Food and Drug Administration on June 21, 2011, tobacco firms have asserted that the warnings violate their First Amendment rights by forcing them to say something they don’t want to about their products and deprive them of their Fifth Amendment rights because the warnings “take” 50% of the front and back panels of a cigarette pack without paying for the space (or the trademarks that appear there).  Both theories share an underlying theory about the nature of the government’s interest in the regulation of tobacco products in general and cigarettes in particular: that the interest extends only so far as to “inform” an adult consumer about product risks. 

That theory, woven through the longer catalogue of tobacco manufacturer complaints about the Family Smoking Prevention and Tobacco Control Act, is actually right on the mark.  Government should care about informing adult consumers.  But, if the definitions of “inform” or “information” are drawn as narrowly as cigarette manufacturers propose, courts will endanger the comprehensive approach Congress deemed necessary to address the social costs cigarettes impose and the tactics cigarette manufacturers use to promote consumption, especially among adolescents.  According to cigarette manufacturers, judges should construct an imaginary world where a consumer (who very probably looks like the judge him or herself) stands in front of a single shelf in a store, in front of a row of cigarette packs, all of which contain the same well-known dangerous ingredients.  Again, according to the manufacturers, the judge should imagine the state with the power to write directly on each cigarette pack the least burdensome, factual characteristics about cigarettes – milligrams of nicotine, milligrams of tar, trace amounts of radioactive metals, etc.  Perhaps the government might also be able to write general warnings about the health implications of smoking.  More than that, the state has violated the freedom of speech.  READ MORE »

Posted in Tobacco, Uncategorized - Tagged ,

The new antismoking warning labels: a necessary step in the right direction

Jul11
2011 Leave a Comment Written by Juan Carballo

On June 21, health officials at the U.S. Food and Drug Administration (FDA) released a series of nine graphic color warning labels that the tobacco industry will be required to include on the top-half of all cigarette packages produced after September 2012. Some of the images are quite explicit in their illustration of the harmful effects of smoking, while others are less vivid, including one portraying a cartoon-depiction of a baby being exposed to a mother’s second-hand smoke, or another of a man wearing a T-shirt that proclaims “I QUIT.” In addition to including images that are meant to inform consumers of tobacco products about the detrimental health consequences of smoking and exposure to second-hand smoke, the packs will also display a toll-free telephone number for smoking cessation services.

One of the approved images

In response to the FDA’s announcement, the four leading companies in the tobacco industry began threatening legal action on the basis that these new images and warning labels would infringe upon their property and free-speech rights by frustrating brand displays, vilifying tobacco companies, and disgracing smokers. The new labels were released as a requirement under the new antismoking legislation, which was signed into law two years ago by President Obama, and which provides the FDA with the power to regulate, though not ban, tobacco products. Despite the tobacco industry’s claims that the consequences of the new law are too intrusive, under both the national and international legal regime, the measures taken by the anti-smoking legislation are not only legal, but also necessary, to effectively curb the use of tobacco products and inform the public about the dangers of smoking.  READ MORE »

Posted in FCTC, National Healthcare, Uncategorized, WHO - Tagged , , ,

The Future of Food Safety

Jun15
2011 Leave a Comment Written by Kate Stewart

Food safety issues are once again in the news.  A large outbreak of E. coli O104:H4, centered in Germany, has sickened more than 3,000 people and killed 35.  After a lengthy investigation, German public health authorities believe the source of the E. coli to be bean and seed sprouts.

This recent outbreak highlights the need for strengthened national and international food safety regulation.  The United States took a large step toward improving food safety earlier this year by enacting the FDA Food Safety Modernization Act (FSMA). In a recent Commentary in the Journal of the American Medical Association, O’Neill Institute Faculty Director Larry Gostin and I addressed the improvements that the FSMA will bring to the U.S.’s food safety system.

As noted in the Commentary, food safety regulation is complex and improving safety requires efforts aimed at primary prevention, surveillance, and response.  The FSMA has been lauded for giving the FDA new mandatory recall authority for food, an enforcement tool it had lacked to date.  Though mandatory recall authority is an enormous boon for the FDA, the current crisis in Germany highlights the importance of a comprehensive “farm-to-table” food safety system.  Mandatory recalls can clearly only be applied when the source of the infection is known.  For this latest outbreak, identifying the source of the outbreak proved difficult.  By requiring producers to adopt preventive control plans and increasing inspections for production facilities, the FSMA moves the FDA toward a preventive approach to food safety. READ MORE »

Posted in Uncategorized - Tagged ,

Welcome to the O’Neill Institute for National and Global Health Law’s Blog!

Jun01
2011 Leave a Comment Written by O’Neill Institute

Dear Colleagues,

Welcome to the O’Neill Institute for National and Global Health Law’s blog.  The blog is meant as a forum for thoughtful dialogue on pressing issues in health law and policy.  It will also be an additional venue for us to keep in touch with our friends and colleagues on current events at the O’Neill Institute, including highlights from our robust research program, graduate degree program, fellowship program, and institute scholarship.

Launched in 2007, the O’Neill Institute at Georgetown University has blossomed into the premier academic research center for national and global health law and policy. Our research encompasses a diverse range of national and global health law topics, from health reform in the US and China, tobacco control globally and in Latin America, global infectious and non-communicable disease prevention, and global health governance. The UN Secretary General recently endorsed the founding vision of the O’Neill Institute—a Framework Convention on Global Health.

We hope that the blog helps us keep in touch with old friends, connects us with new colleagues and partners, and serves as a resource for our readers. Sign up for an RSS feed and check back often.

Thank you for your support of the O’Neill Institute and best wishes.

Lawrence O. Gostin
Linda and Timothy O’Neill Professor and Faculty Director
O’Neill Institute for National and Global Health Law
Georgetown University

Posted in Global Health, National Healthcare, Resources, Uncategorized, WHO - Tagged , , ,

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