Rules of the road: Keeping profits amid regulatory change
Author Robert C. Gallagher once observed that “Change is inevitable—except from a vending machine.” The same can be said about the global (and U.S.) regulatory landscape. U.S. brand owners are often intimidated and bypass global opportunities because the regulatory challenge is daunting.
Well, it is possible to keep the change and profit.
A few rules of the road:
1. Be prepared for Alphabet soup. TGA, SFDA, KFDA, MHRA, CE etc. are all quite real and must be understood. Don’t start the global effort without knowing the fundamentals.
2. There are rules and then there are RULES. Be prepared to disclose some things but hold tight on others. In particular, expect challenges with disclosing product formulations and allowable marketing claims. Provide ranges, not exact formulas. Be ready with clinicals. Be flexible with what can be said on the package — it will probably be pared back from U.S. text.
3) The United States is LIBERAL when it comes to Marketing Claims and packaging text. Understand that the US regulatory world allows more to be said; domestic packaging can include the disclaimer, "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease." This regulatory flexibility, permitted under the Dietary Supplement Health and Education Act of 1994 is especially important in the supplement world. It doesn’t exist anywhere else.
4. Know true International costs of goods sold and product allocation strategy. Going global will not be popular with parts of the domestic organization. Count on increased operational complexity and a battle over limited resources. The allocation of Administrative Overheads, establishing Product Priority and paying for Marketing launches will cause conflict. Global expansion will increase forecasting error; it’s a new business. What happens when (inevitably) WMT and Boots both expect product and it’s not immediately available? On the operational side one “favorite” costing mistake is charging the international changeover costs both startup and shutdown solely to export. Better forecasting and more flexible lead times will become a prized capability. The bottleneck usually occurs with the packaging machinery. Production management is hard pressed to be both cost efficient and nimble at the same time. It’s usually one or the other.
5. Create country clusters if/when possible. This includes grouping required languages, creating an international formulation acceptable across several jurisdictions and, when possible, the equivalent of a consumer safety 800-number serving an entire geographic cluster.
6. Expect bumps in the road. Some ingredients — actives and/or inactives — may be prohibited later on. Over time certain ingredients have come under fire while still allowed in the US. Parabens and Petrolatum come to mind immediately. Be prepared to have the entire production ecosystem scrutinized. This will include Plant inspections and ingredient source traceability. For China, be prepared for the issue of Animal testing. In Canada, Health Canada is serious about French and English content being equal. Also, every container coming into Canada is inspected. Budget for it.
7. Lead Countries can help predict the speed bumps. There are certain countries like Sweden or France that seem to serve as leading indicators of future challenges. The Paraben issue was raised there long before it became a more global issue. Likewise, when predicting Switch activity, New Zealand has been a good bell-weather.
A solid regulatory approach must accompany global expansion. And “keeping the change” can mean big bucks.
Ed Rowland is a Drug Store News contributing editor covering global issues. As the principal of Rowland Global, he believes in the promise of global business and supports companies in their strategy, tactics and execution of international growth initiatives.
NIH division director dispenses diabetes advice in advance of National Diabetes Month
BETHESDA, Md. — For the more than 30 million people in the U.S. with diabetes, the director of the National Institute of Diabetes and Digestive and Kidney Diseases division of the National Institutes of Health urged people to eat better as part of a best practice in taking care of their condition.
"People with diabetes need to make healthy food choices, stay at a healthy weight, move more every day and take their medicine even when they feel good," suggested director Griffin Rodgers in a blog posted Wednesday, the first day of National Diabetes Month. "It’s not easy, but it’s worth it – research has shown that these efforts can dramatically lower the risk of many diabetes-related health problems, including heart, kidney, nerve and eye diseases," he said. "[And] having a network of support can help people with diabetes cope with the daily demands that come with diabetes and help them be more successful in managing their health."
Rodgers noted that the NIH is currently researching a "precision medicine" approach to managing diabetes, where a person’s genes, environment, lifestyle and other factors all help determine the best treatment for that person. "The ongoing Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study is comparing four drugs as additions to metformin, the most common first-line type 2 diabetes medication, to determine which drug works best to manage the disease in different people," he noted.
Even as NIH seeks better pharmacological disease-state management tools for diabetes, people can take better charge of their condition by eating better and exercising, he said. "As we learn more about how to treat and someday prevent all types of diabetes, we hope you’ll use this National Diabetes Month as a chance to take charge of your health," Rodgers concluded. "Go to health visits with questions you may have. Start making small changes to your lifestyle. Learn more about diabetes with free health information from the NIDDK. Find even more ways to improve your diabetes health with the National Diabetes Education Program, a joint program of NIH and the Centers for Disease Control and Prevention."
LifeStyles again partners with Movember Foundation in support of men’s health
ISELIN, N.J. — LifeStyles on Tuesday announced a partnership with the Movember Foundation and its Skyn brand of condoms for the third consecutive year in North America. With a shared commitment to men's health, Skyn will reintroduce their special Movember edition condoms, which are available for purchase at major retailers across the U.S. and Canada.
As part of the partnership, LifeStyles will donate $0.50 from each sale of its 12-count custom Skyn Condoms box to the Movember Foundation (up to $50,000).
"Our continued partnership with the Movember Foundation has given us a larger platform to drive awareness for men's health year after year," stated Jeyan Heper, CEO LifeStyles. "By working with the Movember Foundation for the third year in a row and donating proceeds from sales of our special edition Skyn Condoms, we are supporting men's health and keeping it top of mind, both in and out of the bedroom."
In addition to the availability of Skyn Movember edition condoms at major retailers across the U.S. and Canada, Skyn will also distribute thousands of Movember edition sample packs at college campuses leading up to and throughout the month of November.
Participants who join Skyn's Movember network and raise $50 or more for Movember are automatically entered into the Skyn sweepstakes for the potential to win a three-night trip for two to either: Sedona, Ariz.; Aspen, Colo.; or Jackson Hole, Wy.
"Movember partners have played an extraordinary role in a mission that has helped the Foundation create more than 1,200 men's health projects in 21 countries," commented Adam Garone, co-founder and U.S. Country director at the Movember Foundation. "Our partnership with Skyn Condoms will allow us to expand our brand awareness, reach new audiences – all in an effort to ultimately help men live happier, healthier, longer lives."
The Movember Foundation is the only global charity focused solely on men's health, funding over 1,200 innovative projects across 21 countries. The Foundation raises vital funds for men's health programs supporting these critical areas: prostate cancer, testicular cancer, mental health and suicide prevention.