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

By | Leave a Comment

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 FDA, National Healthcare, Uncategorized; Tagged: , , .


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

By | Leave a Comment

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 FDA, National Healthcare; Tagged: , .


US law and possible Palestinian WHO membership: Implications for WHO funding

By | Leave a Comment

This post was co-authored by Eric A. Friedman and Professor Lawrence O. Gostin.

At the end of October, the United States announced that it would cease funding UNESCO, the UN Educational, Scientific and Cultural Organization, when the agency voted to accept the Palestinian application for full membership, which will make Palestine UNESCO’s 195th member. This immediately raised questions about US funding for other UN agencies in which the Palestinian Authority may seek membership. Under current US law, if the PA seeks full membership in the World Health Organization (WHO) – as reportedly it is interested in doing – the consequences for global health could be dire.

The 1990 and 1994 U.S. laws that led to the cut-off of funding for UNESCO, and could do the same for WHO, bar any U.S. contributions to the UN or any affiliated agency that grants full membership to an organization “without the internationally recognized attributes of statehood,” or to the UN or any specialized agency that grants full membership to the Palestinian Liberation Organization: Read More

Posted in Global Health, Uncategorized, WHO; Tagged: , , , .


Court Enjoins FDA Tobacco Labels

By | Leave a Comment

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 FDA, National Healthcare, Tobacco, Uncategorized; Tagged: , , , , .


The Long March for Life and Dignity: Can a lesson learned in Paraguay help protect Bolivian indigenous communities in the TIPNIS?

By | Leave a Comment

On August 15, 2011, at least 1,000 members of indigenous communities living in the Bolivian Indigenous Territory of the National Park Isiboro-Sécure (TIPNIS) began their long and treacherous march on foot to the capital city of La Paz in hopes of engaging the Bolivian government in a peaceful dialogue to prevent the government from building a highway directly through their territory.  To date, armed with nothing but their will to protect their homes and the park, they continue to march despite the Bolivian government’s violent attempts to disintegrate and stop the movement.  On September 25, as the movement gained momentum with thousands of other Bolivians from different backgrounds supporting what has been called the “VIII Great Indigenous March to Protect the TIPNIS,” the Bolivian government clandestinely sent 500 members of its police force to attack the marchers’ camp at night.  The police beat and sequestered hundreds of men and women, as well as separated children from their parents.  The attack resulted in many injured and led children to flee and disappear for days in the surrounding forests. Hundreds of marchers who were captured and separated from the movement were able to rejoin after their capturers were met with resistance in a town of TIPNIS-supporters.  During the course of their journey, hundreds of people belonging to other indigenous communities joined the march in support of the TIPNIS movement – more than two hundred of them from the Andean region arrived in La Paz two days ago. Now consisting of approximately 2,000, the TIPNIS marchers have walked well over 400 km and are now less than 100 km from La Paz.  Because their arrival would have coincided with judicial elections scheduled to take place on Sunday, October 16, the TIPNIS marchers have postponed their arrival until MondayRead More

Posted in Global Health, Uncategorized; Tagged: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , .


Stay Informed

Signup for our mailing list and stay up to date on the latest happenings at The O’Neill Institute

Or sign up for our RSS Feed

The views reflected in this blog are those of the individual authors and do not necessarily represent those of the O’Neill Institute for National and Global Health Law or Georgetown University. This blog is solely informational in nature, and not intended as a substitute for competent legal advice from a licensed and retained attorney in your state or country.

See the full disclaimer and terms of use.