The Common Rule, the Federal policy protecting human subjects of biomedical and behavioral research, was published in 1991. The process to update the policy has taken place over the last several years, leading to the final rule revisions which were effective as of July 19, 2018. After January 20, 2019, institutions are now permitted to implement the entirety of the revised Common Rule. Any institution receiving funds, supervision, or review from any of the twenty Federal Departments and Agencies that have codified the Common Rule must implement this revised rule in their compliance programs.
With the recent change of New York’s abortion law, legislators granted women the affirmative right to abortions under the state’s public-health law. Under the Reproductive Health Act, restrictions on abortion past twenty-four weeks are removed legalizing abortion up until the day of birth. This bill was passed on the 46th anniversary of the Roe v. Wade decision. The new bill comes as a reaction to the confirmation of conservative Supreme Court Justice Brett Kavanaugh, giving protection to women’s access to abortion if Roe v. Wade is overturned. Proving to be very controversial, the change has advocates and critics at odds with its potential future effects.
The state of Washington is proposing new water quality regulations in an effort to encourage growth to the salmon population. The campaign against the dams in the Columbia and Snake river basins has been fought for decades and continually struggles to balance the environmental impacts with industry and energy. This regulation is the newest strategy to attempt to strike a balance between the environmental concerns and the industry concerns. Further, as more attention is given to the dwindling population of killer whales, many are calling this an emergency requiring immediate action. This action is a timely response to the recent calls to action.
On January 31, 2019, the Trump administration proposed yet another regulation in efforts to control rising prescription costs for Americans. If the regulation becomes final, drug manufacturers and Pharmacy Benefit Managers (“PBM”) will no longer be able to harbor from Anti-Kickback violations when negotiating discounts with Medicare and Medicaid managed care programs. The Administrations, continuing the tone of transparency, will instead provide Medicare Part D beneficiaries with the ability to receive discounted prices at the pharmacy counter. The administration hopes this will allow patients to not endure high out-of-pocket costs by purchasing medications at a more affordable price necessary to sustain their health.
In December 2018, Dr. Christopher Duntsch lost his appeal and the court upheld his life sentence. The name may not sound familiar, but to the medical community in Dallas, Texas, Christopher Duntsch represents what happens when every part of the medical regulatory system fails to protect patients. Christopher Duntsch was given the nickname “Dr. Death” in November 2016 when the DMagazine ran a cover story on him and his victims. In 2018, Wondery produced a six-part podcast series named “Dr. Death” detailing Duntsch’s educational and medical history and the acts that led him to incarceration.
A pair of injunctions in the Northern District of California on January 13, and the Eastern District of Pennsylvania on January 14, halted the implementation of amendments to a religious exemption to the so-called contraception “mandate” of the Affordable Care Act, also known as Obamacare. The “mandate” requires most employers to include contraception coverage in the insurance plans they offer to employees. While Obama administrative agencies contemplated religious exemptions early on, contentious litigation and political transition expanded the scope of the exemption until these latest developments.
“I sometimes wonder if we’re in the branded litter business, branded trash.” That was a presumably half-joking statement made at the World Economic Forum in Davos by Alan Jope, CEO of Unilever, one of the world’s largest consumer goods companies. What certainly was not a joke was the pressure and criticism major consumer goods companies faced in Davos from activists and groups that believe not enough is being done to cut use of plastic packaging in goods. Companies like Coca-Cola and Procter & Gamble (P&G) have emerged as new targets of environmental groups, who see these companies as major contributors to polluted oceans and endangered marine life. The impact of plastic waste on the environment has also drawn the ire of millennials, to the extent that one industry analyst claims the war on plastics is part of consumer goods companies’ marketing plans. While companies may be tailoring marketing plans and making pledges to reduce the amount of plastic in their products, the 8 million tons of plastic that end up in the world’s oceans each year means these companies will continue to feel the heat from activists, millennials, and regulators.
Corporate success was once measured by the numbers on a balance sheet. Today, however, corporations have entered a new era where morals and ethics are increasingly important. Whether this change is a product of outside influence or internal conflict, there is a new trend in corporate culture. Given the business expertise and media-friendly personalities of many CEOs, they may be the leaders chosen to lead the change.
On November 16, 2018, the Department of Education through its Office for Civil Rights, opened a series of proposed regulations for public comment. Interested parties anticipated the release of the regulations for some time, following the Department of Education’s 2017 rescission of the Obama administration’s 2011 “Dear Colleague”. The 2011 letter required educational institutions receiving federal funds to use a preponderance of the evidence standard in adjudicating institutional sexual assault proceedings, among other things. The recent proposal makes that standard permissive, rather than mandatory, while stressing that institutional proceedings must preserve a presumption of innocence on the part of the accused. Though many groups applaud the new proposals, others raise concerns that the proposals stand to harm victims of sexual assault.
Under the Obama administration, the Environmental Protection Agency (“EPA”) and the Army Corps of Engineers promulgated the Waters of the United States rule, which defined “Waters of the United States” to include small bodies of water, such as rivers and wetlands. However, in early 2018, the Trump administration suspended the rule to re-assess the definition. By the end of 2018, the EPA and the United States Department of Army released a new definition of “Waters of the United States,” restricting the definition to traditional navigable waters and their tributaries, certain ditches, certain lakes and ponds, impoundments and wetlands that are adjacent to water specifically covered by the rule.