FDA: No matter that firms market concussion treatments as supplements; they’re unapproved drugs
SILVER SPRING, Md. — The Food and Drug Administration on Thursday issued warning letters to PruTect Rx, of Highlands Ranch, Colo., and Trinity Sports Group, of Plano, Texas, for promoting products labeled as dietary supplements with claims to treat concussions and prevent or treat post-concussion syndrome and other neurological disorders.
The products cited in the warning letters include Trinity Sports Group’s Neuro Impact Concussion Response Formula and PruTect Rx’s NeuroPruTect and Omega3PruTect. These products are in capsule and powder forms. They are marketed online in the United States and internationally.
Under the Federal Food, Drug, and Cosmetic Act, a product is a drug and not a supplement if it is intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease. New drugs may not be legally marketed in the United States without prior FDA approval. Although Neuro Impact, NeuroPruTect and Omega3PruTect are marketed as dietary supplements, they are promoted as drugs through claims made on the firms’ websites.
“The FDA has taken these actions because companies may not sell new drugs unless the drugs have been tested by the sponsor and approved by FDA, and they may not make false or unsubstantiated claims about drugs they sell,” stated Dara Corrigan, the FDA’s associate commissioner for regulatory affairs. “Products with unapproved claims are dangerous because they may cause consumers to delay or avoid legitimate treatments.”
Louisiana pharmacist to Congress: Independents need to stay in the DME business
ALEXANDRIA, Va. — Louisiana pharmacist Randy Mire testified before Congress Tuesday that efforts to combat the diabetes epidemic in his home state and elsewhere would be significantly undermined if independent community pharmacies like his are forced to stop offering diabetes testing supplies as a result of Medicare’s competitive bidding program for durable medical equipment, according to a National Community Pharmacists Association release.
Mire appeared on behalf of NCPA before the U.S. House Small Business Subcommittee on Healthcare and Technology.
“My pharmacy is one of the very few pharmacies still in the area that provides these essential DME supplies to patients,” testified Mire, owner of Gem Drugs, located in Reserve and Gramercy, La. “To me, these patients are more than just a prescription. I provide DME supplies in order to make certain that the beneficiaries have access to the supplies that they need. If I were to decide not to offer these DME supplies because the burden of offering such supplies has become too high and the cost too much, then these beneficiaries would have nowhere else to turn to receive the face-to-face consultations and quality supplies that I provide to them and that they deserve.”
The Bayou State has among the highest diabetes rates in the nation, he noted, and his patients have complained that mail-order deliveries lack adequate patient consultations and are unreliable — a fact driven home by the recent impact of Hurricane Isaac on his community.
Mire urged lawmakers to support H.R. 1936, The Medicare Access to Diabetes Supplies Act. The bipartisan legislation would allow small pharmacies — defined as 10 locations or fewer — to continue to furnish patients with diabetes testing supplies and personalized counseling on their proper use, as competitive bidding is implemented.
NCPA noted that a recently conducted survey of more than 400 community pharmacists found:
About 92% of independent community pharmacies would be forced to leave the Medicare diabetes test supply program if presented with a sharp reduction in payments;
More than 50% of community pharmacies said that the average Medicare diabetic patient comes to their pharmacy at least three times per month for diabetic supplies and/or counseling;
83% of community pharmacists said that the impact on patients if they had to obtain diabetes supplies from mail order would be significant; and
45% of community pharmacies deliver diabetes testing supplies to assisted living facilities. CMS’ current competitive bidding proposal would prohibit these pharmacies from doing so.
NPA bolsters membership services with veteran appointment
WASHINGTON — The Natural Products Association on Tuesday announced that membership marketing expert Gabrielle Alahouzos will be the new VP membership services. Alahouzos most recently served as the director of membership marketing for the National Association of Home Builders, which has more than 160,000 members.
“We’re excited to have Gabrielle on our team, leading NPA on a path to stronger membership growth and retention,” stated John Shaw, NPA executive director and CEO. “Her expertise will be of great benefit to NPA as we work toward improving our membership recruitment efforts.”
For nearly 15 years, Alahouzos has focused on building and maintaining a quality membership experience. In her role at NAHB, she developed an ROI framework to measure their marketing strategy and led the launch of a Net Promoter Score program to improve member feedback and analyze member satisfaction.