The Years Long Process to a Revised Common Rule and Implementation
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.
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.
Government Scrutiny of Patient Assistance Programs
In the eyes of underinsured or uninsured patients, Patient Assistance Programs (PAPs) offer access to otherwise unaffordable medications. However, there are questions being raised whether PAPs are being abused by manufacturers as an inappropriate inducement. The government is increasing its inquiries into PAPs and is beginning to take more investigative action. PAPs are often funded by charitable donations from companies who benefit from the PAP paying for co-insurance for the very drugs the company manufactures. It is essential for companies seeking to develop or maintain charitable donations to remain compliant with existing regulations, but also be aware of forthcoming regulations as a result of present actions.
History of Emergency Prescription Fulfillment Policies in the Wake of Hurricanes Harvey and Irma
In the midst of a natural disaster people gather their children and pets, try to locate a temporary home, and worry what situation they may come home to. The first things people think to grab have nothing to do with their prescription drugs. However, according to a study performed by the U.S. Department of Health and Human Services, from 2011-2014, 46.9% of the population was prescribed a drug in the last 30 days; prescription drugs are an important factor in many peoples’ lives. When portions of the population are displaced from their homes during a natural disaster, they often forget their pill bottles and/or prescriptions. Thankfully, following Hurricane Katrina, regulations were put in place to help people in these situations.
Pharmaceutical Representatives in Chicago Soon to be Subject to Strict Licensing Requirements
Kimberly Seay Associate Editor Loyola University Chicago School of Law, J.D. 2018 On November 16, 2016, the City Council approved an ordinance amending Chicago Municipal Code § 4-6-010(c)(30), which will require the licensing of all pharmaceutical sales representatives in order to endorse pharmaceuticals within city limits and is set to take effect July 1, …
Mother and Son Sentenced to Federal Prison for Pharmacy Fraud Scheme
Anais Holland-Rudd Associate Editor Loyola University Chicago School of Law, JD 2018 Niurka Fernandez, 54, and her son Roberto Alvarez, 26, both plead guilty on August 31, 2016 to one count of conspiracy to commit health care fraud. On November 10th, Fernandez was sentenced to 120 months in prison while Alvarez was sentenced to …
Mylan Medicaid Fraud Investigations
Kaitlin Lavin Executive Editor Loyola University Chicago School of Law, JD 2017 Mylan has already been under public scrutiny for increasing the price of its EpiPen allergy shots. Last week the State of West Virginia launched a Medicaid fraud investigation questioning Mylan’s price hike and compliance with drug rebate laws. Mylan Pharmaceuticals participates in …
Big Pharma Scorecard Encouraging Greater Clinical Trial Transparency
Kaitlin Lavin Executive Editor Loyola University Chicago School of Law, JD 2017 Bioethics International (BEI), a non-profit organization, is working to improve transparency and ethics in healthcare delivery and innovation by holding pharmaceutical companies accountable for compliance with the Food and Drug Administration Amendments Act (FDAAA). Many people do not trust drug companies, believing …