INSIDE COMPLIANCE – Page 72 – Loyola University Chicago School of Law

Senators Urge FDA to Update Its Regulation on Products Containing Hemp and Hemp-derived Compounds

February 22, 2019Drugs & Devices

On January 15, 2019, Senators Ron Wyden and Jeff Merkley sent a letter to the U.S. Food and Drug Administration (FDA) urging the agency to update its federal regulations governing the use of certain cannabis-derived ingredients in food, beverages and dietary supplements. As writers of the Hemp Farming Act, Wyden and Merkley, initiated the removal of the hemp plant and derivatives of Cannabis sativa from the list of controlled substances under the Controlled Substance Act. The Hemp Farming Act passed as a provision in the Agriculture Improvement Act of 2018, and thus, legalized the production and sale of industrial hemp and hemp-derived compounds, including cannabidiol (CBD).

CBDFDA

The Future of Roe v. Wade

February 21, 2019The Art of Compliance

Roe v. Wade has been a controversial Supreme Court decision ever since it was decided in 1973. Critics have tried to overturn it multiple times over the years. Some states have attempted to circumvent the ruling and implement their own abortion laws, while other states have implemented laws to solidify it in the event the decision is overturned. On the 46th anniversary of the opinion, New York passed a new abortion law called the Reproductive Health Act, which has caused an uproar across the country. In addition, this month the Supreme Court ruled to stay on a Louisiana Targeted Regulation of Abortion Providers (“TRAP”) law. The question becomes how will states comply with the ruling of Roe v. Wade when its future seems unknown.

abortionconstitutionalityJournal of Regulatory ComplianceRoe v. WadeSupreme CourtTRAP laws

The Issue with Attorney Conflicts of Interest in the Entertainment Industry

February 20, 2019Uncategorized

All attorneys, in every jurisdiction in which they are admitted to the bar and in every area of practice, have an obligation to comply with that jurisdiction’s Rules of Professional Conduct. However, the past few decades have shed light on the unusual practices of attorneys in the entertainment industry, particularly on how they handle conflicts of interest. Generally, these attorneys encourage clients to waive conflicts of interest, and those clients are all too happy to do so. This practice only serves to further blur the lines in an already complicated area of legal ethics.

attorney ethicsconflictsconflicts of interestentertainment industrylegal ethicsmusic industryRule 1.7

Tax Compliance During the Partial Government Shutdown

February 15, 2019Compliance Spotlight, Uncategorized

On December 22, 2018, for the third time in a year, the United States government shut down. Almost two years into his presidency, President Trump, feeling pressure to accomplish one of his many promises from the campaign trail, requested $5.7 billionfrom Congress to fund his proposed wall at the border of the United States and Mexico. Following negotiation efforts by Senate Democrats, the standoff between the President and the Senate ended in a financial default, triggering a partial shutdown. The shutdown became the longest in U.S. history on January 19, 2019, beating the previous 21-day recordset by the 1995-1996 shutdown. The shutdown left an estimated 380,000 government employeeslocked out of work without pay and an even greater 420,000 employees working for no compensation at all, including employees of the IRS. With one of the United States’ most important governmental bodies being almost completely stalled by a lapse in funding, it begs the question: what happens to taxes during a shutdown?

Journal of Regulatory Compliancetax

Pressing Pause: A Survey of Regulatory Recovery After the Government Shutdown

February 14, 2019Fraud & Abuse

Although the nation’s longest-ever government shutdown has ended, agencies forced to furlough employees and shutter temporarily are still facing the effects of the funding gap. On January 25th, President Trump agreed to sign a continuing resolution that will reopen and fund the federal government through February 15th. The government reboot means that the roughly 800,000 federal employees furloughed or forced to work without pay should expect to receive their back pay soon, but the thirty-five-day suspension of government functions comes with significant aftershock. While various regulatory agencies scramble to address their backlog of work, life for Americans who interact with these agencies has been hindered indefinitely.

complianceFDAgovernment shutdownIRSJournal of Regulatory ComplianceSEC

FINRA Releases Regulatory Notice Announcing 529 Plan Share Class Initiative

February 14, 2019Finance & Banking

On January 28, 2019 the Financial Industry Regulatory Authority (FINRA) released Regulatory Notice 19-04 announcing a 529 Plan Share Class Initiative encouraging firms to self-report potential violations. Broker-Dealers are encouraged to consider self-reporting under the initiative if they have identified specified failures in connection with 529 plan recommendations, and have the ability to assess the impact of the failures. Firms have until April 1st to notify FINRA in writing if it has decided to self-report.

broker-dealerfinancial regulationFINRATax Cuts and Jobs Act

The Years Long Process to a Revised Common Rule and Implementation

February 13, 2019Drugs & Devices

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.

Clinical Research Complianceclinical testingcompliancecompliance programFDAHHShuman test subjectsimplementationJournal of Regulatory CompliancepharmaceuticalpolicyRegulationthe common rule

“On Demand” Abortions: Protection for Women’s Rights or Expansion of Late-Term Abortions?

February 12, 2019HIPAA & Health Information

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.

abortion accessGovernor Andrew Cuomonew yorkRegulationReproductive Health ActRoe v. Wade

Changing Washington Water Quality Standards for Salmon Survival

February 8, 2019Uncategorized

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.

Columbia RiverColumbia River BasincompliancedamsEndangered Speciesendangered species actEnergyenvironmental impact statementEnvironmental Protection Agencyenvironmental regulationGovernor Jay InsleeHydropowernational oceanic and atmospheric administrationninth circuitNOAARegulationrulemakingsalmonSouthern Resident Killer WhalesSouthern Resident OrcasState of WashingtonTDHWashington Statewater quality standards

Trump Administration’s Proposal to Update Anti-Kickback Safe Harbors Gives Patients Drug Price Relief at the Pharmacy Counter

February 7, 2019Compliance Spotlight, Fraud & Abuse

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.

AKSAmerican Patients Firstcompetitioncompliance programDirect DiscountsDrug Manufacturersdrug pricing blueprintHHSincentivesMedicare Part DPBMpharmacyPharmacy Benefit Managerrebatessafe harbortransparencyTrump Administration