The Food and Drug Administration (FDA) regulates dietary supplements products and ingredients. FDA's jurisdiction is granted by the Dietary Supplement and Health Education Act (1994). Manufacturers and distributors of dietary supplements are responsible for evaluating the safety of their products and ensuring that the labeling is compliant with the Federal Food, Drug & Cosmetic Act and [...]
The Food and Drug Administration recently issued an inspection report pertaining to Downing Labs for failing to investigate why its drugs fail sterility tests. Last year, FDA requested that Downing Labs recall some of its drugs after determining that there was contamination. At that time, Downing Labs refused the request. Now, however, the pharmacy has announced a voluntary [...]
Serenity Hospice and Palliative Care will pay $2.2 million to the federal government to settle claims that it falsely billed Medicare. A former employee identified that Serenity flagged patients who were referred by one medical provider to ensure that they were admitted as hospice patients. In turn, Serenity would treat that provider's staff to dinner, concerts and [...]
The debate about specialty drugs involves determining if a new drug will cure a disease, or save lives, what is its proper cost? Some well-intentioned drug products are receiving scrutiny for the price pharmaceutical are looking to sell those drugs. Patients can rarely afford a product that costs nearly $100,000 a year. Insurers are reluctant to cover those [...]
Salads are popular items. Cucumbers are too. Recently though, a Texas woman became the second person to die from tainted cucumbers. A salmonella outbreak has been linked to cucumbers sold by a California company. Strains of salmonella in cucumbers grown in Mexico and distributed out of San Diego have been on health officials' radars in [...]
Recently, the Food and Drug Administration approved OxyContin, an extended-release form of the opioid painkiller oxycodone, for children as young as 11 who need “daily, round-the-clock, long-term” pain relief that can’t be treated adequately with other medications. While some physicians and parents applaud the decision, others have criticized the decision noting that it exposes children [...]
A former top administrator filed claims under the Federal False Claims Act — also known as a qui tam action in Georgia. Columbus Regional Healthcare System and Dr. Andrew Pippas have agreed to settle claims that they fraudulently billed governmental insurers. Dr. Pippas agreed to pay $425,000 to settle billing claims against him. Columbus Regional agreed [...]
Mobile health apps have the potential to make doctors more efficient and reduce the cost of health care. In addition, these apps can increase patient satisfaction and understanding, while empowering them to take charge of their own health. One of these includes Medscape. Medscape is free and is also the fastest growing medical app with [...]
Individuals who witness physicians, physician groups and hospitals billing for services and products that were not provided are started to speak up. Qui tam actions permit individuals to file a civil suit, under seal, for filing false claims. Often these actions are filed in federal court because they may involve reimbursement issues related to Medicare [...]
Entrepreneurs are embracing the advantages technology can bring to traditional "brick and mortar" businesses. This is true in the healthcare setting as well. Teladoc is a company that connects patients and doctors over the telephone and internet. Earlier this year, the Texas Medical Board ("TMB") issued rules regarding telemedicine. Teladoc filed suit to prevent the implementation of [...]
