Tag:

Regulation

A Way Around HHS 340B Program Delays

Access to quality, comprehensive health care services seems to always be at the forefront of our health care industry. One’s ability to gain access measured in terms of utilization, is dependent upon financial affordability, and physical accessibility. While a seemingly small issue under the overarching ‘access to health care’ topic, talks about access to medication and its affordability in particular for the vulnerable and underinsured patients must also be addressed. A number of health organizations have sued HHS for delaying the implementation of rules that would force drug companies to be transparent about their pricing and punish them for overcharging participating hospitals in the federal program that discounts outpatient medication. Due to HHS’ delays, hospitals cannot challenge drug manufacturers for overpricing outpatient medication thus they cannot access refunds of discounts that are due to them under statute. 

GDPR, Data, & Blockchain: The New Wonders of the Digital World

In a world where our reliance on technology and the cloud is increasing exponentially, data security’s growth has stagnated. The European Union (EU) passed the General Data Protection Regulation (GDPR) in hopes of ensuring that consumer data is protected and not harbored by businesses. The effects of the GDPR, however, have passed the borders of the European Union. In a world where our actions extend internationally with just the click of a button, the GDPR’s impact circles the globe as well. The GDPR has pushed for a shift in data privacy and regulation for companies within and outside of the EU as it holds to protect European citizens, no matter where they are in the world. This international reach has not only created forces to drive U.S. companies to comply, but states within the U.S. are now creating GDPR-inspired laws to protect their own citizens. The GDPR has started a trend that will soon become the norm and finally push compliance to keep up with the exponential growth of technology.

Can Congress Regulate Big Pharma?

Drug companies need to fund the research and development necessary to create better products. This means that pharmaceutical companies have fought for years to maintain control over the prices of said drugs. But this standard is being challenged with a new bill that was introduced to the House of Representatives on June 25, 2018.

The Food Safety Modernization Act is Just the Beginning of the FDA Compliance We’ve Been Waiting For

Despite the United States having one of the safest food supplies in the world, more than 48 million Americans get sick from foodborne illnesses and diseases each year, and more than 128,000 are hospitalized and 3,000 die from similar issues that are largely preventable. On January 04, 2011 President Obama signed the Food Safety Modernization Act (“FSMA”) into law. This enactment was called the “most sweeping reform” of U.S. Food Safety laws in more than seventy years. But seven years later, the act is still only partially enforced as the FDA has faced resistance from the government as well as a lack of funding. The FMSA was and is intended to enable the FDA to protect the health of the public by strengthening the food system in the United States. While change and reform in the industry are necessary, what good are new reforms if they will not be enforced for years to come?

Trump Administration Deregulates Housing

As President Donald Trump continues to deliver on his promise to deregulate, the Department of Housing and Urban Development (HUD) has been instrumental in reversing Obama-era regulations.  President Trump, who made his fortune in real estate development, has a checkered past when it comes to fair housing and discrimination.  Now his administration is working to cut funding to HUD and unwind many fair housing and discrimination rules.  Administration proponents say this is a necessary step to fix a broken and corrupt bureaucracy, while many advocates have expressed concern over the government scaling back enforcement of fair housing laws.  Any reform effort should seek to balance concerns about bureaucracy with the vital missions of fair discrimination-free housing, inclusive communities, and civil rights.  

Deregulation of Uranium Mining or: How I Learned to Stop Regulating and Love the Bomb

Compliance professionals all over the country are paying close attention to the Trump administration’s deregulatory campaign. While deregulation in finance has received the most media attention, the uranium mining industry has been a quiet beneficiary of the President’s new regulatory scheme.

How will the Supreme Court’s new rule barring the government from refusing offensive trademarks affect the marketplace?

On June 19, 2017, the Supreme Court, in an 8-0 ruling, found that the government can no longer sensor trademarks on the grounds that they may be offensive. In Matal v. Tam, the Supreme Court Justices found the seventy-one year old rule allowing the government to refuse offensive trademarks to be unconstitutional and to violate free speech and first amendment rights. The justices were unable to agree on exactly what legal standard was to apply to the present case or future cases. The revocation of this seventy-one year old rule that has affected the registration of many marks over the years is bound to have an effect on the future of trademark law and trademark litigation. Immediately following the Supreme Court’s decision, the United States Patent and Trademark Office (USPTO) was inundated with requests to register offensive trademarks.

Trump Administration Deregulates Financial Services

The Trump administration is delivering on its promise to deregulate America.  Since taking office, numerous regulations spanning everything from energy to health care have been repealed or weakened.  The financial services industry is not immune to the deregulation movement.  The Trump administration is acting through appointments, executive agencies, and legislation to deregulate the financial services industry.  Proponents of deregulation claim the movement is needed after Dodd-Frank and strict post-financial crisis regulation.  However, in deregulating financial services, the Trump Administration—and compliance professionals—should proceed cautiously. 

What Does a Federal Government Shutdown Mean for Compliance?

For the first time since 2013, on Saturday, January 20th, 2018, the U.S. government ran out of money when Congress failed to pass a spending bill to fund the federal government. Much of the federal government’s operations have ground to a halt due to the lack of funding. Because Congress is seemingly at an impasse over immigration policy, the shutdown may last several days, if not weeks. In light of Loyola’s upcoming symposium exploring what happens when regulation is not enforced, it is interesting to consider how, in a similar vein, the shutdown affects compliance.