A federal appellate court on Monday sided with pharmaceutical industry interests to overturn the conviction of Alfred Caronia, a pharmaceutical sales representative who sold and promoted drugs for off-label use, on First Amendment grounds. This decision sets the stage for a potential Supreme Court case that would have enormous consequences for the Food and Drug Administration (FDA), and potentially shift the contours of how the pharmaceutical industry is regulated in America.

The Second Circuit Court of Appeals in Manhattan found by 2-1 margin that Caronia was simply exercising his right to free speech while promoting a drug — which has been officially approved by the FDA to treat narcolepsy — as a suitable treatment for insomnia, along with several other medical conditions for which it was not intended. While doctors have the authority to prescribe medication for purposes other than a drug’s intended use, drug manufacturers are subject to a higher level of scrutiny in the way they promote their products’ uses, and firms such as Johnson&Johnson have had to dole out big settlements to the Justice Department in recent years for violating these standards and promoting off-label use.

While the appellate court ruled that Caronia was within his constitutional rights to discuss the alternative effects of the drug he was promoting, government officials and dissenting Judge Debra Livingston warned that the Second Circuit’s wide-ranging decision could open up a can of worms that leads to an asymmetric level of power and discretion for pharmaceuticals, while stripping the FDA of its ability to safeguard Americans’ health by effectively regulating drug makers:

“Most if not all of these cases have been based on a central premise: that it is unlawful for a company and one of its employees to be promoting a drug or a medical device off-label,” said John R. Fleder, a director at the law firm Hyman, Phelps & McNamara who represented the F.D.A. while working at the Justice Department. “And this decision hits at the heart of the government’s theory.” [...]

Under the Food, Drug and Cosmetic Act, which gives the F.D.A. the authority to regulate drugs, selling a “misbranded drug,” or one that is intended to be used for purposes not listed in the label, is illegal. Doctors, on the other hand, are free to prescribe a drug for any use. The agency has argued that off-label promotion of drugs is evidence that a sales representative or company intended to sell misbranded drugs. [...]

The lone dissenting judge [in the court's decision], Judge Debra Ann Livingston, vigorously disagreed, arguing that by throwing out Mr. Caronia’s conviction “the majority calls into question the very foundations of our century-old system of drug regulation.” She argued that if drug companies “were allowed to promote F.D.A.-approved drugs for nonapproved uses, they would have little incentive to seek F.D.A. approval for those uses.”

If the decision is upheld in a review by the full Second Circuit bench or the Supreme Court, the FDA will have to significantly modify its approach to overseeing the drug industry. Former FDA chief counsel Gerald Masoudi says that the ruling will force the FDA to “focus on the kinds of speech that are more likely to harm consumers, such as false or misleading marketing versus something that is not approved” in future dealings with pharmaceutical promotion and advertising.

This is not the only major drug industry case that may soon be headed to the Supreme Court. As ThinkProgress reported, the Supreme Court decided Monday to review a case asking whether bio-tech drug company Myriad Genetics can patent two human genes for a cancer-prevention screening procedure.

Employees at Catholic institutions might not be as opposed to President Obama’s contraception laws as Republican politicians seem to think. According to a new report out today from Campus Reform, the faculty and staff at Catholic colleges donated in droves to President Obama’s re-election campaign.

Of the employees who donated to a presidential campaign, 91 percent chose to donate to Obama, with high-dollar donations going hugely for Obama over Mitt Romney. Of the 826 individuals who donated more than $200, only 78 gave that high sum to Romney. There were six Catholic colleges at which not a penny went to Romney.

This information is congruous with what previous evidence has already proven about Catholic voters: They did not buy into Republican arguments that Democrats are eroding religious liberties. But it is notable particularly for the fact that it shows Catholic employees did not feel threatened by Obama’s contraception mandate — the Obamacare requirement that all employers must provide copay free contraception to their employees — despite the drumbeat of arguments all election season that Obama’s health reform law goes against the wishes of Catholic voters.

A new Health Affairs study finds that Americans enrolled in so-called “consumer-driven” or high-deductible health insurance plans are likely to forgo crucial preventative care services because they don’t realize those services are cheap, or even free, with their coverage.

High-deductible plans — which increasing numbers of employers are beginning to offer to their workers — charge enrollees lower monthly premiums, but significantly higher out-of-pocket deductibles. And Kaiser Health News reports, consumers enrolled in those plans often don’t know that certain services — such as regular screenings and checkups — don’t carry the same high out-of-pocket price tag as the other services on their plan, leading them to skip out on that preventative care:

A survey of hundreds of Californians enrolled in health savings accounts, one type of high deductible plan, showed that fewer than one member in five understood that preventive care was free or almost free. A fifth of those surveyed said they had avoided preventive examination or treatment because of cost.

“It’s a reminder that patients usually have a pretty limited understanding of the details of their health insurance plan,” Mary Reed, a Kaiser Permanente scientist and the study’s lead author, said in an interview. ”Even when plans are designed well or thoughtfully, if patients don’t understand they probably won’t behave accordingly.”

The lesson doesn’t apply just to high-deductible plans, she said. The need for member education is rising as all plans “continue to get relatively more complicated,” she added.

High-deductible health plans attempt to lower health spending by shifting costs onto Americans, forcing them to choose between exorbitant out-of-pocket costs and forgoing treatment for many of their medical services. And the fact that such a high number of Americans are choosing the latter, even for their preventative services that would have been covered, exposes the dangerous nature of high-deductible plans — and serves as a stark reminder that Americans don’t necessarily have much in-depth knowledge about what their health care plans or providers’ policies include. For instance, a recent survey found that Americans are still largely uncertain about what Obamacare means for them.

This trend has troubling implications for high-deductible plans. If Americans under those plans continue to skip out on preventative care because they falsely believe they will be charged high out-of-pocket costs, then those insurance pools will simply become sicker and costlier. Fortunately, Obamacare requires employers to distribute materials to their employees to properly educate them about their plans’ benefits and costs — a provision that is now particularly important for the Americans who are skipping care because they’re unsure about what their high-deductible plans will cover for them.

Another new survey shows that a majority of Americans agree with an Obamacare mandate that insurance plans should include contraception coverage at no additional cost — even for religiously affiliated organizations, or in cases where an employer says providing coverage for birth control conflicts with their beliefs.

The Lifeway Research poll found that 63 percent of adults say businesses should be required to provide contraception coverage for their employees, while 56 percent say nonprofits like schools and charities should have to. And 53 percent say that Catholic organizations should also have to meet the Obamacare mandate.

In a similar poll in October, 54 percent of Catholics specifically reported they believe religiously affiliated groups should comply with the mandate. Dozens of court challenges have been filed against the contraception mandate. Hobby Lobby in particular is continuing to fight against the requirement that it provide its employees with contraception coverage; the craft chain filed an appeal in November after a federal judge ruled the company must comply with the health care law.

The 2013 guidelines for the United States’ premiere program for addressing global HIV/AIDS contains a new provision that explicitly prevents it from funding contraceptives and other “family planning commodities.” This provision isn’t mandated by Congress; it’s a purely executive decision that hurts women’s health and rights in the developing world. So why is it there?

The provision is a part of the new Country Operational Plan Guidance for the President’s Emergency Plan for AIDS Relief (PEPFAR), a program created in 2003 to centralize America’s efforts in the fight against HIV/AIDS. The 2013 version, issued in October, says that “PEPFAR funds may not be used to purchase family planning commodities,” a phrase that did not appear in the past three versions of the same document. Moreover, the new version also threatens aid workers who violate these strictures, saying “all USG personnel should be aware of legal restrictions and program requirements relating to family planning, and should consult with relevant Agency legal counsel with any questions in this area.” The insertion of these provisions is at the discretion of PEPFAR’s administrator, the Office of the Global AIDS Coordinator (OGAC), and is not mandated by the original PEPFAR legislation nor the 2008 reauthorization of the bill.

This change isn’t heralding a new policy: PEPFAR has had a restriction on purchasing for family planning commodities for quite some time, but this report is the first time that it’s been formally codified in this fashion. The technical guidance also specifies that PEPFAR may purchase and distribute condoms, providing no formal definition of “family planning commodities” but specifying clearly that contraceptives count.

Nonetheless, the family planning restriction in PEPFAR has been devastating for women’s health. A report from the Guttmacher Institute calls contraception “an important intervention” in preventing the spread of mother-to-child AIDS in Africa, finding that “current levels of contraceptive use among HIV-positive women living in Sub-Saharan Africa may already be preventing some 173,000 HIV-positive births annually.” The report notes that, although other forms of U.S. foreign aid provide contraception (which is PEPFAR’s defense of its policy), those efforts are not enough:

[I]t is undeniable that USAID’s family planning program is currently underfunded and under attack, and unless funding is increased immediately, there will be a serious shortfall of resources to meet the growing demand. At $615 million annually, U.S. funding for family planning is only a fraction of what it should be to meet the needs of women in the developing world, of which 215 million want to avoid a pregnancy but are not using an effective method of contraception. U.S. advocates have been calling for at least $1 billion annually. A recently released report by five former directors of the Population and Reproductive Health Program at USAID goes even further, making the case that funding for USAID’s family planning budget be set at $1.2 billion—and raised to $1.5 billion by fiscal year 2014.11 But these increases are unlikely if congressional House leaders have their way. Three times in 2011 alone, the Republican House has moved to slash funding for international family planning aid.

Moreover, the Guttmacher researchers note, PEPFAR operates in some countries that do not receive other family-planning assistance from U.S. agencies. Those include the three countries with the highest rates of HIV prevalence in the world (Swaziland, Botswana, and Lesotho).

The Obama Administration has made some positive moves on increasing access to family planning abroad. It has overturned the “Mexico City Policy” that defunds all NGOs that even mention abortion and has issued a blueprint document suggesting that PEPFAR plans to improve on its contraception policy going forward. However, anti-AIDS advocates have been critical of cuts to PEPFAR proposed by the Administration.

When Hurricane Sandy slammed the East Coast at the end of October, flood damage and power outages forced some of New York City’s hospitals to evacuate their patients and staff, and public health officials anticipated that those hospitals would have to remain closed for at least several months. And now, a little over a month after the superstorm swept across the city, New York City’s remaining hospitals are starting to feel the strain after picking up increased patient loads.

The New York Times reports that medical professionals are scrambling to compensate for the fact that the emergency rooms and inpatient services at four New York City hospitals remain closed in the wake of Hurricane Sandy — particularly since the superstorm damaged the facilities at Bellevue Hospital Center, the city’s premiere public hospital and high-trauma center. The influx of patients to the city’s other hospitals is causing long lines and staff shortages:

“It’s like a World War II ward,” Teri Daniels, who had been waiting a day and a half with a relative who needed to be admitted, said last week.

Since the storm, a number of New York City hospitals have been scrambling to deal with a sharp increase in patients, forcing them to add shifts of doctors and nurses on overtime, to convert offices and lobbies to use for patients’ care, and even, in one case, to go to a local furniture store to buy extra beds. [...]

Emergency room visits have gone up 25 percent at NewYork-Presybterian/Weill Cornell, which in Bellevue’s absence is the closest high-level trauma center — treating stab wounds, gun wounds, people hit by cars and the like — in Manhattan from 68th Street south. Stretchers holding patients have been lined up like train cars around the nursing station and double-parked in front of stretcher bays.

Hospitals are also struggling to accommodate an influx of psychiatric patients, due to both displaced patients from damaged adult homes and increased anxiety levels triggered by the storm.

Just last week, the New York Health Department warned that, although the superstorm has passed and the news cycle has largely moved on, New Yorkers still face a “significant risk of serious illness or death” in the aftermath of Hurricane Sandy. Power has been restored to the city, but an estimated 12,000 New Yorkers are still living without heat in their homes, contributing to a spike in cold-exposure cases over the past month.

Public health officials worry about the situation worsening as the winter months bring even colder temperatures — particularly because the New Yorkers who visit emergency rooms to be treated for hypothermia may have a long wait in front of them.