FDA targets dietary supplements maker for selling unapproved, misbranded drugs
SILVER SPRING, Md. The Food and Drug Administration on Wednesday announced that Toby McAdam and Greta Armstrong, doing business at Rising Sun Health and The Center for Complementary and Alternative Health of Livingston, Mont., have signed a consent decree that prohibits them from manufacturing and selling unapproved new drugs and adulterated or misbranded dietary supplements in violation of the law.
Prior to entry of the consent decree, Rising Sun manufactured and distributed a variety of unapproved new drugs under such names as Black Salve, Cansema and Can-Support. These products included topical salves purported to treat skin cancer, as well as oils and capsules claimed to be therapies for other serious diseases, such as breast cancer, asthma, anemia and epilepsy. Rising Sun misbranded many of these unapproved new drugs as dietary supplements.
“The FDA will not tolerate unsubstantiated health or disease claims that may mislead customers,” stated Deborah Autor, director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research. “The FDA is committed to ensuring that consumers do not become victims of false cures.”
Under the consent decree, Rising Sun agreed to stop making and selling unapproved new drugs and products with unauthorized health claims. Rising Sun also agreed to hire an independent expert to review the claims made for future products and to certify that all violative claims have been omitted. The FDA can order Rising Sun to stop manufacturing and distributing any product that fails to comply with the consent decree or the Federal Food, Drug, and Cosmetic Act. The consent decree also provides for damages to be assessed against Rising Sun in the event of such violations.
The consent decree was filed in the U.S. District Court for the District of Montana and is subject to court approval.
H.D. Smith subsidiary launches new website
WOOD DALE, Ill. Smith Medical Partners, a business focused on specialty pharmaceutical distribution and solutions, announced the launch of its new company website.
The H.D. Smith subsidiary said its new site, Smpspecialty.com, features a user-friendly platform that includes audience-specific landing pages, including relevant products and FAQs tailored for unique segments of the healthcare industry.
Additionally, the site also will feature Smith Medical Partners news, reimbursement announcements, recall postings and industry developments, as well as e-newsletters that are tailored for multiple specialty practices, placing Smith Medical Partners customers among the first to receive details on new product launches, special purchasing opportunities and program information.
“Our online visitors will now experience a more comprehensive and vibrant view of Smith Medical Partners,” said Smith Medical Partners VP David DuRoss. “We have taken a strategic approach to providing rich content in an accessible and streamlined layout.”
Foundation for HealthSmart Consumers: New OTC reimbursement rule will be costly
WASHINGTON A panel of healthcare thought leaders has concluded that a recent IRS rule change requiring a written prescription so that over-the-counter medicines can be eligible for reimbursement under flexible spending accounts will demand retail system challenges that are operationally impossible to overcome in the time frame required.
“We see this as a threat to consumer access and choice at a time when we need our citizens to be more engaged in managing their health and the cost of care,” stated Jon Comola, executive director of the Foundation for HealthSmart Consumers. Because of the new rule change, Comola said, “some consumers are likely to seek prescriptions for OTCs or alternative [prescription] drugs in order to comply with the new tax requirement.”
According to Foundation researchers, the resulting costs could reach $2.5 billion annually if office visits and lab tests are incurred by even 10% of the insured population; potential new pharmacy costs could reach $3 billion annually.
“We are concerned about the negative impact on people who are using OTCs to address health issues like smoking cessation, weight control, arthritis and allergies because of the increased tax on higher cost products,” said Jim Parker, fellow for The Foundation. “This may result in increased physician visits and potentially the prescribing of more expensive prescription drugs.”
The number of consumers who take advantage of health spending accounts is not insignificant, the Foundation added. “More than 50 million of the 195 million commercially insured consumers have healthcare accounts and will be directly affected by this new rule,” noted Roy Ramthun, president HSA Consulting.
As of Jan. 1, consumers will no longer be able to pay for most OTC medicines with funds from their flexible spending accounts and other health accounts (including HSAs and HRAs) unless the OTCs are “prescribed.” Retailers already are taking steps to warn shoppers of the new restrictions on purchases of OTC medicines using funds from their healthcare accounts.
This rule change, enacted as part of the Patient Protection and Affordable Care Act, is intended to help fund increases in healthcare spending in other parts of the bill.