FDA initiates Secure Supply Chain Pilot Program with 13 prequalified pharmaceutical distributors
SILVER SPRING, Md. — The Food and Drug Administration on Tuesday announced the initiation of the Secure Supply Chain Pilot Program to enhance the security of imported drugs.
In August 2013, the FDA published a notice in the Federal Register (78 FR 51192) to solicit companies to voluntarily submit applications for participation in this two-year program. Thirteen prequalified companies have now been designated to take part, and will receive expedited entry for the importation of up to five selected drug products into the United States.
The goal of the program is to enable the FDA to evaluate resource savings that will allow the agency to focus imports surveillance resources on preventing the entry of high-risk drugs that are the most likely to compromise the quality and safety of the U.S. drug supply.
“By creating incentives for manufacturers to adopt best practices for supply chain integrity, we can enhance the quality and safety of imported drugs,” stated Carol Bennett, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “The program also allows the FDA to focus resources on the areas with the greatest potential risk to consumers.”
During these next two years, the FDA will evaluate the program’s effectiveness at enhancing imported drug compliance with FDA regulations and the security of the drug supply chain. If the FDA determines the program to be effective, a more permanent program may be established and possibly extended to additional participating companies.
The prequalified companies accepted into the program that will receive expedited entry, are the following:
- Astellas U.S. Technologies;
- Bristol-Myers Squibb Company;
- Celgene Corporation;
- GE Healthcare;
- Merck Sharp & Dohme Corporation;
- Mylan Pharmaceuticals;
- Novartis Pharmaceuticals;
- Teva Pharmaceutcials USA; and
- Watson Laboratories.
Each of the 13 companies met multiple participation conditions, including:
- Committing to comply with requirements of the Food, Drug, and Cosmetics Act;
- Having a validated secure supply chain protocol per the U.S. Customs and Border Protection’s Customs-Trade Partnership Against Terrorism program;
- Having a plan in place to quickly correct potential problems the FDA identifies regarding importation of specific products;
- Having effective recall and corrective action plans in place; and
- Maintaining control over their drugs from the time of manufacture abroad through entry into the United States.
FDA approves Northera
SILVER SPRING, Md. — The Food and Drug Administration announced that it has approved Northera capsules (droxidopa) for the treatment of neurogenic orthostatic hypotension.
NOH is a rare, chronic drop in blood pressure upon standing that’s associated with Parkinson’s disease, multiple-system atrophy and pure autonomic failure. Symptoms include dizziness, lightheadedness, blurred vision, fatigue and fainting when a person stands.
“People with neurogenic orthostatic hypotension are often severely limited in their ability to perform routine daily activities that require walking or standing,” said Norman Stockbridge, M.D., Ph.D, director of the Division of Cardiovascular and Renal Drugs in the FDA’s Center for Drug Evaluation and Research. “There are limited treatment options for people with NOH, and we are committed to helping make safe and effective treatments available.”
Northera received orphan-product designation from the FDA; it is made by Charlotte-based Chelsea Therapeutics.
Diplomat Pharmacy contributes to expansion of N.E.W. Life Center facility
FLINT, Mich. — The N.E.W. Life Center, a Flint-based ministry supported by Diplomat Pharmacy, on Tuesday expanded its facility, the specialty retailer announced.
The community program is based out of the former St. Luke’s Catholic Church on Lawndale Avenue. N.E.W. Life Center founded N.E.W. Life Enterprises, a business that produces scrubs and hospital gowns for use in medical facilities along with other sewn items. The renovation and expansion will house work stations for the seamstresses.
St. Luke’s is located in Flint’s Civic Park neighborhood, which is protected by state and federal restrictions as a historic area. Plans to build a new facility have been put on hold as Diplomat works with the city and state to determine if new construction can be permitted. With current demand for products from N.E.W. Life Enterprises resulting in a two-month backlog of orders, additional delays would have been problematic. Diplomat stepped in to fund the $10,000 project to renovate the facility’s 4,000 square foot gymnasium into useable workspace. Sixty work stations have been built along with new light fixtures, electrical wiring and ceiling fans.
The final stages of the renovation and moving process were completed Saturday, Feb. 15, by teams of volunteers from Diplomat and Siwek Construction.
Currently N.E.W. Life Enterprises employs 26 women in full-time positions. The additional space will allow the business to add 20 new jobs and increase work capacity. “Diplomat’s goal is to support the Sisters and NEW Life Enterprises,” stated Phil Hagerman, Diplomat CEO.