This post was written by Madhu Chugh. Ms. Chugh is a scholar at the O’Neill Institute at Georgetown University Law Center and an attorney at Wilmer Cutler Pickering Hale and Dorr LLP. The views expressed in this post are the author’s alone and do not reflect the views of WilmerHale or the O’Neill Institute.
Mitt Romney has promised that one of his first orders of business, if elected President, would be to dismantle the Affordable Care Act (ACA), President Barack Obama’s signature health reform law enacted in March 2010. In order to repeal the ACA, a President Romney would need Congress’s cooperation. If Congress (perhaps the Senate in particular) refused to back repeal, the question would arise: What could a Romney Administration do, based solely on executive authority, to slow or undermine the implementation of the ACA? If elected, Mr. Romney would have a few options at his disposal to impede how the law is carried out. Commentators elsewhere have discussed how Mr. Romney could curtail implementation through rulemaking and other avenues. This post analyzes two other potential tools in a President’s arsenal—namely “waiving” state compliance with the ACA and defunding the programs created by the law. Read More
This post was written by Lawrence O. Gostin, Faculty Director of the O’Neill Institute. and was originally published in the JAMA Forum on October 18, 2012.
The “Repeal and Replace” Strategy
Romney’s preferred strategy to repeal and replace the ACA would undoubtedly rely on a parliamentary tactic called the budget reconciliation process, the very method by which the Democratic-controlled Congress enacted the ACA.
Throughout most of the passage of the ACA, the Democrats held a filibuster-proof majority. By the time Democratic Senator Edward Kennedy of Massachusetts died in August 2009 and a by-election was held the following January to replace him, the ACA had passed both Houses of Congress. But the House and Senate versions were very different. After the election of Republican Scott Brown to Kennedy’s vacant Senate seat, the Democrats lost their supermajority, and the only way the bill could reach President Obama’s desk was through the budget reconciliation process. And that is what transpired: the ACA passed without a single Republican vote. Although Republicans denounced this parliamentary maneuver, they used it themselves to enact the Medicare drug benefit. For Romney, budget reconciliation would be the only feasible way to repeal the ACA. Read More
In the Institute’s last blog posting, Tanya Baytor commented on how large manufacturers of unhealthy foods, including Coca-Cola, McDonald’s and Cadbury’s, took advantage of the Olympics to associate their products with health. Tanya raised the concern that these companies’ exclusive Olympic sponsorship deals helped them market to children, a segment of the population which is especially susceptible to food marketing and which suffers from epidemic levels of obesity and overweight.
At the Clinton Global Initiative two weeks ago, the Global Fund to Fight AIDS, Tuberculosis and Malaria announced that it would be expanding its partnership with Coca-Cola called Project Last Mile. Under this project, Coca-Cola lends its supply chain management expertise to help the Global Fund improve delivery of essential medicines to clinics in hard-to-reach rural areas, starting in Africa. (Rather than including medicines in shipments of Coke, a plan which was considered but scrapped, the company works with Accenture to help host country governments improve distribution networks.) The project was piloted in Tanzania, where, according to the Daily Beast, “delivery times have been cut from 30 days to five. When patients seek vaccination, they find the right one in 80 percent of cases, up from 50 percent two years ago.”
Over the past two weeks, the 2012 Olympic Games have showcased remarkable athletic achievements in varying feats of skill, speed, strength and agility and are a testament to the boundless potential of the human body. The Olympic Games are—or at least should be—a source of inspiration for children around the world to lead healthy, active lives, particularly in the face of a growing global obesity epidemic. Yet, as you know if you’ve tuned in to watch even one event, the world’s largest junk food manufacturers—Coca-Cola, McDonald’s, and Cadbury’s—are nearly as prominent as the athletes themselves. Through exclusive sponsorship deals with the International Olympics Committee (IOC), these companies have used the Olympics to associate their brands with athleticism and success and beam their advertisements promoting unhealthy products into the homes of millions of children across the globe. Many have hailed the London Games the ‘best ever’, but as the global epidemic of childhood obesity marches on, we should ask ourselves whether we really want soda and fast food companies sponsoring international sporting events.
The Childhood Obesity Crisis and the Impact of Food Marketing
The obesity epidemic is emerging as one of the world’s most pressing public health challenges of our time with a staggering 170 million children estimated to be overweight globally. Obesity places children and adolescents at risk for a range of serious health problems, including cardiovascular disease, diabetes and depression, making obesity second only to smoking as a cause of preventable death. While industrialized nations have long faced childhood obesity, the epidemic is spreading at an alarming rate in low-income countries as their populations gain greater access to processed, low-nutrient foods. Indeed, over two-thirds of the world’s population now lives in countries where overweight–related health issues cause more deaths than underweight-related issues. Treating obesity and obesity-related conditions costs billions of dollars a year. In May 2012, the U.S. Institute of Medicine estimated that the annual cost of obesity-related illness in the U.S. alone is more than $190 billion, equal to 21 percent of annual medical spending. Such costs are unsustainable globally. Read More
Posted in Global Health;
The Food and Drug Administration announced today its approval of tenofovir-emtricitabine (aka Truvada) for HIV prevention. Truvada, which has been approved since 2004 for use in HIV treatment, is now approved for use as preexposure prophylaxis (“PrEP”)–a strategy in which an HIV-negative person uses an antiretroviral drug (in this case a daily pill) to reduce the risk of acquiring HIV from behaviors such as unprotected sex. [More info on this strategy from CDC and AVAC.]
Although the approval had been anticipated–an advisory committee recommended approval in May–there had remained questions about the parameters of the approval:
(1) Populations: clinical trials have demonstrated clear (albeit partial) efficacy of Truvada among men who have sex with men and heterosexual couples in which one partner is HIV positive and the other is negative, leading the advisory committee to vote overwhelmingly to approve for these populations. However, the data among heterosexual women are more mixed. As a result, the advisory committee’s vote on whether to approve for “other individuals at risk for acquiring HIV through sexual activity” was a close call at 12-8. Today, FDA announced that Truvada would be approved for anyone “at high risk of HIV infection and who may engage in sexual activity with HIV-infected partners”–a win for women’s health advocates who supported broader access, citing the vulnerability of many women to HIV exposure from male partners who refuse to use condoms.
(2) Risk mitigation: the FDA‘s decision was originally fast-tracked with a target date of June 15, but pushed back with the announcement that the FDA would be considering new materials on the Risk Evaluation Management Strategy (REMS) from the drug’s manufacturer. This topic had received extensive discussion among the advisory committee, and for those skeptical of PrEP as a public health intervention, it was key: concerns about the drug’s safety (risks of kidney damage and bone density loss) and drug resistance (among those who become HIV infected and continue taking Truvada instead of full-on ARV therapy) had led some to suggest strict limitations to control access, e.g. only to patients who could show a negative HIV test. Instead, the FDA‘s announcement described a REMS based on education for providers and patients, explaining that stricter limits would have added “unnecessary burdens to health care professionals and patients.”
Less strict requirements may be important for patients with less consistent access to health systems, many of whom may face elevated HIV risk. The CDC is expected to issue new clinical practice guidelines for PrEP, and the debate over how best to roll out this intervention–safely, effectively, and equitably–will certainly continue.
Posted in Uncategorized;
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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.