News

Drug makers, beware: FDA is watching

BY Alaric DeArment

WHAT IT MEANS AND WHY IT’S IMPORTANT Drug companies had better take a close look at their portfolios and make sure they aren’t marketing unapproved drugs. Any excuses they might have for making prescription drugs without regulatory approval will go unheeded by Food and Drug Administration officials.

(THE NEWS: FDA shuts down unapproved Glenmark, Konec drugs. For the full story, click here)

It seems simple enough, but a number of drugs on the market today entered the market long before the FDA adopted its current drug regulations, meaning that despite being commonly prescribed, they’re technically illegal.

The FDA started the unapproved drugs initiative in 2006 to bring these so-called “grandfathered” drugs into compliance with current policies. Most recently, it sent warning letters to Glenmark Generics and Konec to stop marketing nitroglycerine tablets. Last April, it warned nine companies to stop manufacturing unapproved narcotic drugs, including Boehringer Ingelheim, which had been marketing unapproved morphine and oxycodone products since 1983.

In the short term, the FDA’s actions don’t usually lead to shortages. The agency said Pfizer made nitroglycerin tablets in the same strengths as Glenmark and Konec, and the two companies would be given three months to stop manufacturing the tablets and six months to stop shipping them, rather than having to pull drugs from pharmacy shelves. In the cases when shortages do happen, the FDA has been known to temporarily suspend its warnings to drug makers; anticipating a shortage after its action against the nine companies last year, the FDA allowed the continued marketing and distribution of high-concentrate morphine sulfate oral solution on an interim basis.

And regardless, drug makers can still get approval: In January, the FDA approved Roxane’s morphine sulfate oral solution.

“An important goal of the unapproved drugs initiative is to make sure that marketed drugs meet current FDA standards,” FDA Center for Drug Evaluation and Research deputy director Douglas Throckmorton said at the time. “Our action today reflects a careful balance between ensuring patient access to necessary medicines, while making sure companies comply with the law.”

 

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

News

Rite Aid accepting EBT cards, food stamps at stores

BY Michael Johnsen

CAMP HILL, Pa. Rite Aid on Thursday announced that all Rite Aid pharmacies now accept EBT (electronic benefit transfer) cards and food stamps provided through the Supplemental Nutrition Assistance Program.

“One-in-eight Americans are receiving food assistance through SNAP, according to the USDA,” stated Brian Fiala, Rite Aid EVP store operations. “With nearly 4,800 Rite Aid stores nationwide offering assorted groceries, accepting EBT cards is just another convenience we can offer to our customers and help make their lives a little easier.”

SNAP, formerly known as the Food Stamp Program, is administered by the USDA and offers families and individuals at certain income levels financial assistance in purchasing food and beverages. Electronic Benefits Transfer is the electronic system that allows a SNAP recipient to authorize transfer of their government benefits from a federal account to a retailer account to pay for products received. SNAP benefit recipients are issued EBT cards that look like debit cards.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

News

Report: Food Lion pulls plug on Bloom stores expansion

BY Allison Cerra

RALEIGH, N.C. Food Lion has pulled its plans to bring four Bloom stores to the North Carolina market, according to local reports.

The four stores, which currently are under construction, will become Food Lions instead. Spokeswoman Christy Phillips-Brown said the company will focus on increasing the number of Bloom stores in existing markets rather than expanding into new ones.

The Bloom chain, which was introduced in 2004, has 66 stores, including one opening in Charlotte this week. The stores are known for such tech-savvy features as scanner guns and recipe kiosks.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES