On April 24, the O’Neill Institute hosted a presentation by two visiting scholars from the Shanghai Food and Drug Administration (SHFDA). Mr. Ji Chen is the Deputy Director of the Department of Drug Sale and Marketing Control at the SHFDA headquarters. Mr. Junhua Wu is the Senior Drug Inspection Officer of the Pudong Branch of the SHFDA. READ MORE »
Posts tagged FDA
A committee formed by the Institute of Medicine (IOM), National Academy of Science, and chaired by O’Neill Institute for National and Global Health Law Faculty Director and Georgetown University Law Center Professor Lawrence Gostin has issued a new report, “Countering the Problem of Falsified and Substandard Drugs,” which offers recommendations to the United States and globally on protecting citizens against the health risks posed by illegitimate medications.
The full release can be viewed here: http://www.law.georgetown.edu/oneillinstitute/documents/GostinNationalAcademyPressRelease.pdf
Check out the NPR report featuring Professor Gostin as well: http://www.npr.org/blogs/health/2013/02/13/171923516/report-action-needed-to-curb-fake-and-substandard-drugs.
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 »
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 »
This post was authored by O’Neill Institute research assistant and third-year Georgetown University Law Center student Mirona Dragnea.
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 »
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 »
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.
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 »
This post authored by O’Neill Institute Research Assistant and rising Georgetown Law 2L, Dinesh Kumar.
In a 6-3 decision on June 23, the Supreme Court ruled unconstitutional a Vermont law prohibiting pharmacies from selling prescriber-identifiable drug information to “data mining” companies. These companies aggregate and sell this data (which doesn’t identify patients) to pharmaceutical companies, which promote sales through targeted “detailing” of doctors’ offices. The plaintiffs-respondents (which included PhRMA as well as major data miners IMS Health, SDI, and Source Healthcare Analytics) argued that the law curtailed their First Amendment commercial speech rights by impeding the ability of drug companies to interface with doctors, and the Court agreed.
Noting that the law particularly targeted industry detailing (i.e., the law did not prevent healthcare research organizations or journalists from using the data), Justice Kennedy in the majority opinion said the law discriminated on the basis of the speaker and content of the speech—a fundamental First Amendment violation. Kennedy was also disturbed by Vermont’s contention that detailing should be curbed because it was too effective in influencing doctors’ treatment decisions: “[F]ear that speech might persuade provides no lawful basis for quieting it.”
The Court upheld the opinion of the Second Circuit, which had previously overturned a district court ruling that the law was constitutional. Two other laws banning data-mining that predate Vermont’s, in Maine and New Hampshire, had been upheld by the First Circuit in recent years, but the Supreme Court had not taken up the issue until Sorrell. The Maine and New Hampshire laws are virtually identical to Vermont’s in regards to the scope and purpose of their restrictions on the sale of prescriber-identifiable date. READ MORE »
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 »