The Federal Food, Drug, and Cosmetic (FDC) Act of 1938 requires pharmaceutical drugs to provide evidence of their safety before they are allowed on the market. As such, pharmaceutical companies submit applications to the Federal Drug Administration for approval. There are situations, however, in which patients seek to receive access to a particular pharmaceutical drug before the FDA approval process is complete. This blog will explore the various pathways to pre-approval access in addition to recent legislation and legal considerations for such pathways, in addition to the principles and common obstacles that pharmaceutical companies face within such pathways.
The ability to access experimental drug treatments has long been contentious in the United States. Prior to the 1938 Food, Drug & Cosmetic Act, pharmaceutical drugs were largely unregulated. This Act required, for the first time, that drugs sold to the public were safe. Increasing regulations regarding the marketing, testing, and distribution of pharmaceutical drugs were established throughout the next fifty years. In the 1980s, however, a puzzling illness became known to the public. This illness was called HIV/AIDS, a debilitating virus that caused the body’s own immune system to attack itself. This illness has killed over 32 million people in the United States and worldwide, and particularly impacted the population of gay men. Because homosexuality was still fairly taboo in the 1980s, many argue that the country dragged its foot in researching and approving treatment for HIV/AIDS. Due to significant advocacy, much progress has been made with this particular illness, and the country has slowly evolved from the slow and strict processes that once regulated potential pharmaceutical drug treatments.
The Health Insurance Portability and Accountability Act – enacted in 1996 by the U.S. Congress and signed by then-President Bill Clinton – has long served to maintain the standards of electronic health records and patient privacy, among many other provisions. Violating HIPAA can result in both criminal prosecution as well as steep civil penalties. As the healthcare industry transitioned from the use of paper records to storing patient data on electronic health records over the last two decades, health organizations have learned to adapt to HIPAA compliance, with many increasing their compliance programs by hiring full-time compliance officers, designating an individual as the compliance manager, and/or appointing a compliance committee within the organization.
On March 27, 2020, President Donald J. Trump signed into law the Coronavirus Aid, Relief, and Economic Security Act (H.R. 748), otherwise known as the “CARES” Act. Originally introduced in January as the Middle-Class Health Benefits Tax Repeal Act, the bill was then revised to address the needs of the United States amid the coronavirus pandemic. The bi-partisan CARES Act, with strong support from the White House, ultimately passed the House of Representatives with a 419-6 roll call and the Senate with 96-0 votes.
In the United States, a mortgage is considered “conforming” if it meets the guidelines of Freddie Mac (the Federal Home Loan Mortgage Corporation) and Fannie Mae (the Federal National Mortgage Association). Both Freddie Mac and Fannie Mae buy mortgages, pools them, and then sells them back to the open market for investors. In 2008, the federal government put both organizations into a conservatorship due to the financial meltdown and subsequent economic recession. As such, the government now has stringent guidelines that homebuyers must meet if they want to qualify for a Freddie Mac or Fannie Mae mortgage.
The rapid evolution of electronic health records has dramatically changed the healthcare system in the past two decades. Healthcare organizations, both large and small, have transitioned from paper records to hybrid records, and then finally, for many organizations, to completely electronic data. In 2009, the American Reinvestment & Recovery Act (ARRA) created the federal “Meaningful Use” program. This program essentially amounted to a significant government subsidy for practices transitioning to electronic health records and provided funding for organizations to purchase electronic health records subscriptions from health information technology companies in exchange for complete adoption, implementation, and the regular development of quality reporting measures using the new software.
At first glance, the Fair Housing Act is fairly straightforward: one must not discriminate on the basis of race, color, national origin, religion, sex, familial status, or disability. These classes are protected by federal law and applicable universally in the United States of America. In practice, however, the fine line complying with FHA anti-discrimination laws and complying with internal leasing policies – aimed at protecting the company from high-risk renters — can be difficult to discern for apartment leasing agents.
In October of 2017, the downfall of disgraced sexual harasser Harvey Weinstein made national news and started what is now popularized as the #MeToo movement. Since then, numerous people have come forward to share their stories of workplace harassment in various industries. This leaves those in the human resources and/or compliance departments with a two-fold task: (1) protecting their employees, and (2) protecting the organization from legal liability regarding sexual (and other forms of) harassment in the workplace.