FDA Warning and Close-Out Letters

As part of its regulatory compliance activity, the U.S. Food and Drug Administration (FDA) issues warning and close-out letters.  There are three types of warning letters, reflecting the nature of the compliance violation and the corrective action required from the violator.

This article describes each type of warning letter, and provides a backdrop to our subsequent posts on the actual warning letters sent by the FDA.

 

General FDA Warning Letters

When FDA finds that a manufacturer has significantly violated FDA regulations, the agency notifies the manufacturer in the form of a warning letter.  A general warning letter identifies the violation, such as poor manufacturing practices, problems with product claims, or incorrect directions for use of a product.

The general warning letter also requires that the company must correct the problem following specific directions and within a timeframe.  The company is required to inform FDA of its plans for correction.  Upon the implementation of the corrections, the FDA then checks to ensure that the company’s corrections are adequate.

Tobacco Retail Warning Letters

Specific regulations guide the sale and distribution of certain products, such as alcohol and tobacco.  For example, the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), restrict the sale of cigarettes and smokeless tobacco to children and adolescents.  Compliance inspections of tobacco retailers occur periodically, and the checks are conducted to determine a retail establishment’s compliance with these regulations.  Retailers in violation of the law and applicable regulations receive FDA warning letters.

Drug Marketing and Advertising Warning Letters (and Untitled Letters to Pharmaceutical Companies)

These letters are sent electronically via the Internet to web sites that offer to sell online prescription drugs that may be illegal.  The letters warn these web site operators that they may be engaged in illegal activities and inform them of the laws that govern prescription drug sales.  Some of the letters are edited to remove confidential information.

Warning Letter Close-Out Letter Program

FDA may issue a close-out letter once the agency has completed an evaluation of corrective actions undertaken by a firm in response to a warning letter.  A close-out letter will not be issued based on representations that some action will or has been taken.  The FDA must actually verify the corrective actions.  Usually, the standard for verifying that corrections have been implemented is a follow-up inspection. If the warning letter contains violations that by their nature are not correctable, then no close-out letter is issued. This close-out procedure applies to FDA warning letters issued on or after September 1, 2009.

 

© Copyright Rachel Agheyisi, Report Content Writer and Regulatory Compliance Digest Blog, 2012

 

 

FDA Enforcement Report – January 18, 2012

The FDA publishes a weekly Enforcement Report, which details product recalls and field correction activity of the agency.  It is a vital resource for both industry and consumers.  Each report provides information about recalled products, including:

 

  

• product name and code
• manufacturer and/or distributor
• volume of product in circulation
• geographical distribution of product
• reason for the recall
• risk category of the recalled product.

 

Potential contamination with E. Coli, and undeclared product ingredients were among the reasons for some of the Class I food product recalls  in this week’s report.  Deviations from established good manufacturing processes accounted for some Class II drug product recalls.

 

CLICK HERE for the complete January 20, 2012 report.

 You may also want to see our article, which provides a helpful overview of the FDA product recall process.

 

© Rachel Agheyisi, Report Content Writer, Regulatory Compliance Digest Blog, 2012

Price Gouging Alert: CVS Caremark Corporation Settles FTC Deceptive Pricing Charges

CVS Caremark Corporation will pay $5 million to settle Federal Trade Commission charges that it misrepresented the prices of certain Medicare Part D prescription drugs – including drugs used to treat breast cancer symptoms and epilepsy – at CVS and Walgreens pharmacies. The allegedly deceptive claims caused many seniors and disabled consumers to pay significantly more for their drugs than they expected and pushed them into the “donut hole“.  The donut hole is a term referring to the coverage gap where none of their drug costs are reimbursed – sooner than they anticipated or planned.

The settlement will bar deceptive claims related to Medicare Part D drug prices and require CVS Caremark to pay $5 million to reimburse affected Medicare Part D consumers for the price discrepancy.

Many U.S. consumers choose their Medicare Part D drug plans by looking up plan benefits and drug prices on website of CVS Caremark’s subsidiary, RxAmerica, by going to the Centers for Medicare & Medicaid Services website and using the web-based tool Plan Finder, or by visiting other third-party websites, which post the necessary information.

The FTC charged that from 2007 through at least November 2008, RxAmerica posted on its website and supplied for posting to Plan Finder and third-party websites incorrect prices for Medicare Part D prescription drugs at two pharmacy chains, CVS and Walgreens.  In some instances, the actual prices for these drugs were as much as 10 times more than the posted prices. Because of the deceptive price claims, many elderly and disabled consumers chose RxAmerica plans and paid significantly more than they expected for their drugs at CVS and Walgreens.

The proposed settlement order bars CVS Caremark from misrepresenting the price or cost of Medicare Part D prescription drugs or other prices or costs associated with Medicare Part D prescription drug plans. It requires that CVS Caremark pay $5 million in consumer refunds. The FTC will be mailing checks to eligible consumers who were harmed by these misrepresentations after the order becomes final. The settlement also contains standard record-keeping provisions to allow the FTC to monitor compliance with its order.

The FTC will publish a description of the consent agreement package in the Federal Register shortly. The agreement will be subject to public comment for 30 days, beginning February 12, 2012 through Feb. 13, 2012, after which the Commission will decide whether to make the proposed consent order final.

Score another one for the U.S. consumer!

© Copyright Rachel Agheyisi, Report Content Writer and Regulatory Compliance Digest Blog, 2012

FDA Enforcement Report – January 11, 2012

The FDA publishes a weekly Enforcement Report, which details product recalls and field correction activity of the agency.  It is a vital resource for both industry and consumers.  Each report provides information about recalled products, including:  

 

 

• product name and code
• manufacturer and/or distributor
• volume of product in circulation
• geographical distribution of product
• reason for the recall
• risk category of the recalled product.

 Product labeling issues feature prominently in the FDA’s activity this week.

 CLICK HERE for the complete January 11, 2012 report.

 

 You may also want to see our article, which provides a helpful overview of the FDA product recall process.

Health Fraud Alert — Don’t Be Fooled By Scams

According to the U.S. Food and Drug Administration (FDA), the snake oil salesman is still alive.

The FDA should know – the agency was formed in 1906, to among other things, protect consumers from “snake oil salesmen” and other shifty characters who swindled the sick and gullible.  Over a century later, the FDA is still on the case.

Health Fraud Back Then — A Little Bit of History

Back in the early days of the FDA, the enforcement activity focused on traveling con men who sold tonics and elixirs — such as “miracle oil” supposedly made from snakes — with promises to cure all ailments.  Labels did not list ingredients and unsuspecting buyers only found out through bitter experience that they were at best ineffective and at worse deadly.

Rampant health fraud was a significant reason for the passage of the 1906 Food and Drugs Act, which prohibited the marketing of adulterated and misbranded drugs, and required labeling of a few ingredients, including alcohol, opium, morphine, heroin, and cocaine.

 Health Fraud Today — New Tricks, Same Outcomes

According to Gary Coody, national health fraud coordinator at FDA, health fraud is still pervasive today because, among other things, the Internet has opened up the world market to everyone.  People can access all manner of products from all over the world, by using a few clicks on their computers.

 The modern day snake oil salesmen are savvy marketers who have devised a variety of tricks to parlay their ware.  Flashy websites, TV infomercials, radio, direct mail, word-of-mouth marketing and ads in newspapers and magazines, all persistently up the hype.

 The schemes can take many forms.  Some products billed as “all natural” in fact have prescription drugs and other chemicals not listed on the label that could be dangerous.  The most common categories of these tainted products include weight loss, sexual performance, and bodybuilding products.

 Coody’s advice to consumers is to view these product ads with a healthy dose of skepticism.  The waste of money is bad enough but using unproven treatments can delay getting a potentially life-saving diagnosis and medication that works.

 Buyer Beware — Red Flags for Fraud

To equip consumers with the right kind of information, the FDA recently created a new Internet resource to help consumers recognize health fraud and protect themselves.

 FDA’s Health Fraud Scams website pulls together videos and articles on how to avoid fraudulent schemes, and offers information about products that have been seized, recalled or are the subject of warnings from the agency.

 The site also provides links to government resources on health fraud involving FDA-regulated products, such as drugs, dietary supplements, tobacco products, alternative medicines, medical devices, and cosmetics.  Anyone can search the site to see if FDA has taken an action against a product or company.

CLICK HERE to access the FDA’s health fraud scams website.

Here are some easy-to-spot red flags to keep in mind:

• CURE ALL! For unrelated diseases
• QUICK FIX! Within days
• ANCIENT REMEDY! Or a secret formula
• REVOLUTIONARY! Or new science
• AMAZING RESULTS! Difficult to verify
• MY TUMOR SHRUNK! Unproven testimonials
• ACT NOW! Limited availability
• LOSE WEIGHT! No diet or exercise
• MONEY-BACK GUARANTEE!

© Copyright Rachel Agheyisi, Report Content Writer and Regulatory Compliance Digest Blog, 2012

Marketers Beware: Stiff Penalties for Deceptive Advertising and Unfair Billing

The U.S. Federal Trade Commission (FTC) announced that Phoenix-based Central Coast Nutraceuticals, Inc., an operation that marketed acai berry supplements, colon cleansers, and other products using allegedly fraudulent free trial offers and phony endorsements from Oprah Winfrey and Rachael Ray will pay $1.5 million as part of a settlement.

The case against, is part of the FTC’s ongoing efforts to protect consumers from fraudulent internet marketing, as well as false and misleading health claims. The FTC charged that the defendants violated the Federal Trade Commission Act, as well as the Electronic Fund Transfer Act and its implementing language, Regulation E.

Victimized consumers flooded law enforcement agencies and the Better Business Bureau with thousands of complaints about Phoenix-based Central Coast Nutraceuticals.

The 2010 FTC complaint alleged that two individuals and five related companies deceptively claimed that their Acai Pure supplement would cause rapid and substantial weight loss, and that their Colotox colon cleanser would prevent colon cancer.  Also, despite claiming to offer a “free” trial for a nominal fee and full refunds upon request, the defendants allegedly repeatedly made unauthorized charges to consumers’ bank accounts, and made it all but impossible to avoid paying full price for the products, typically $39.95 to $59.95.

At the request of the FTC in August 2010, a federal court halted the allegedly illegal conduct of the Central Coast Nutraceuticals defendants, imposed an asset freeze, and appointed a receiver to oversee the corporate defendants.

The settlement order against the defendants includes an $80 million judgment, which represents the total amount of consumer injury caused by their scheme. The monetary judgment will be suspended when the FTC receives assets worth approximately $1.5 million from the defendants.

The money will be made available for consumer refunds.

In addition to banning the defendants from selling any products or services with a negative option feature, the settlement also prohibits them from the following:

• making deceptive statements that there is no cost for a trial purchase; that all consumers who request full refunds will get them; that celebrities such as Oprah Winfrey and Rachael Ray endorse their products; that consumer testimonials reflect typical consumer experiences; about the total amount consumers will pay; or about any other material fact regarding any goods or services sold by the defendants;
• failing to make adequate disclosures about the material terms and conditions of any offer;
• charging consumers’ credit cards, or debiting their bank accounts without their consent;
• making any claim that a product can diagnose, cure, mitigate, treat, or prevent any disease, including cancer, unless the claim is approved by the Food and Drug Administration;
• making any claim that a product can cause weight loss, unless the claim is supported by two well-controlled human clinical studies;
• making claims about the health benefits of any supplement, food, or drug without competent and reliable scientific evidence, and misrepresenting any tests or studies;
• making deceptive or false statements or failing to disclose material facts, to a payment processor or financial institution; and
• violating the Electronic Funds Transfer Act and Regulation E.

CLICK HERE for more information about the FTC alerts on free trial offers, products that claim to treat, prevent or cure diseases, and weight loss products.

 

  

© Copyright Rachel Agheyisi, Report Content Writer and Regulatory Compliance Digest Blog, 2012

FDA Warns About Stem Cell Claims – Information You Should Know

Stem cells, sometimes called the “master cells,” are the precursor cells that develop into blood, brain, bones and all of the body’s organs.  These cells have the potential to repair, restore, and regenerate, which explains their promise in the treatment of diseases and medical conditions for which few treatments exist.

The Food and Drug Administration (FDA) regulates stem cells in the U.S. to ensure that they are safe and effective for their intended use.  Different cell types are used for different purposes.

Currently, the FDA has approved only one stem cell product, Hemacord, a cord blood-derived product manufactured by the New York Blood Center and used for specified indications in patients with disorders affecting the body’s blood-forming system.

Because of the yet untapped potentials, the FDA is concerned that the hope that patients have for cures not yet available may leave them vulnerable to unscrupulous providers of stem cell treatments that are illegal and potentially harmful.  The agency cautions consumers to make sure that any stem cell treatment they are considering has been approved by FDA or is being studied under a clinical investigation that has been submitted to and allowed to proceed by FDA.

As part of the FDA review process, stem cell sponsor must show how the product will be manufactured so that FDA can make certain that appropriate steps are being taken to help assure the product’s safety, purity and potency.  FDA also requires that there be sufficient data generated from animal studies to aid in evaluating any potential risks associated with the use of these products.

FDA Advice for Consumers

The agency wants consumers to be aware that at present–other than cord blood for certain specified indications–there are no approved stem cell products.  Specifically, consumers should take the following cautionary steps:

• If you are considering stem cell treatment in the U.S., ask your physician if the necessary FDA approval has been obtained or if you will be part of an FDA-regulated clinical study. This also applies if the stem cells are your own. Even if the cells are yours, there are safety risks, including risks introduced when the cells are manipulated after removal.
• Know the risks.  For example, there is a potential safety risk when cells are put in an area where they perform a biological function that is different from their role in their original location in the body.  Cells in a different environment may multiply, form tumors, or may migrate somewhere else.
• If you are considering having stem cell treatment in another country, learn all you can about regulations covering the products in that country.

CLICK HERE for a full copy of the FDA article.

© Copyright Rachel Agheyisi, Report Content Writer and Regulatory Compliance Digest Blog, 2012

FDA Targets Gastric Band Weight-Loss Claims

Side bar:  If you are a regular reader of this blog, you know we routinely draw attention to bring news from various U.S. regulatory agencies, such as the Federal Food and Drug Administration (FDA).  Today, we decided to report the FDA’s latest alert on weight loss procedures.

 

What follows is the FDA’s article in its entirety.  If you’d like a copy go to: http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/UCM282422.pdf

 

Ready to be the next weight-loss success story?

Let your new life begin!

I lost 90 pounds with the Lap-Band!

Sounds tempting, doesn’t it? The Food and Drug Administration (FDA) has seen many claims similar to the ones above, but there’s a catch.

There can be serious risks with the weight-loss surgery and medical implant promoted by these ads, so FDA is taking action.

FDA has warned eight surgical centers and the marketing firm 1-800-GET-THIN LLC in California about misleading advertising of the Lap-Band—a device implanted in a surgery called gastric banding to help adults eat less and lose weight.

The ads—splashed on billboards, bus placards, newspaper advertisements, the Internet and elsewhere—feature slender, smiling men and women claiming they lost massive amounts of weight and gained control of their lives after Lap-Band surgery.

“FDA’s concern is that these ads glamorize the Lap-Band without communicating any of the risks,” says Steven Silverman, director of the Office of Compliance in FDA’s Center for Devices and Radiological Health. “Consumers, who may be influenced by misleading advertising, need to be fully aware of the risks of any surgical procedure.”

By federal law, product advertising for certain medical devices, such as the Lap-Band, must contain relevant warnings and information about precautions, side effects, and contraindications (medical reasons that make a treatment inappropriate).

FDA’s warning letters direct the California marketing firm and surgical centers to pull their misleading ads and to notify FDA within 15 working days of action taken to correct them.

Two Gastric Bands Approved

FDA has approved two gastric bands: Lap-Band, by Allergan Inc., and Realize Adjustable Gastric Band, by Ethicon Endo-Surgery Inc. These devices are implanted around the upper part of the stomach to create a “pouch.” The small pouch limits the amount of food that can be eaten at one time, making you feel full faster and potentially lose weight.

Both bands are approved for use in adults age 18 and older who have not lost weight with non-surgical methods, such as diet, exercise or behavior modification, and have

• a body mass index (BMI) of at least 40. (BMI is a measure of body fat based on an adult’s height and weight. A 5-foot-6-inch person weighing 248 pounds has a BMI of 40.)

or

• a BMI of at least 35 (217 pounds at 5-foot-6 inches) and at least one health condition linked to obesity, such as diabetes or high blood pressure.

Allergan’s Lap-Band is also approved for those with a BMI of 30 to 34 who have a health condition related to their obesity.

The Risks

“Surgery itself has risks, including death, and those risks are heightened for people who are obese,” says Herbert Lerner, M.D., a general surgeon and supervisory medical officer at FDA.

There are risks after the surgery, too, including

• nausea and vomiting
• difficulty swallowing
• gastroesophageal reflux disease (GERD)
• upset stomach or pain
• stretching of the stomach pouch
• stretching of the esophagus
• moving of the gastric band, requiring another surgery to reposition it
• erosion of the band through the stomach wall and into the stomach, requiring another surgery

“Most people lose weight with the gastric band,” says Lerner. “However, one should not assume that a gastric band is a permanent device. A good number of people require another operation to reposition, replace or remove the gastric band sometime during their life due to complications or because they have not lost weight.”

No Binging Allowed

Gastric banding requires a drastic diet change—you need to eat small portions frequently to prevent complications and ensure weight loss, says Lerner. “If you eat or drink more than your stomach pouch can hold, the pouch will stretch and food may back up into the esophagus. You may have nausea and vomiting, and require an adjustment of the band.”

And if patients eat a lot of fattening foods or drink milkshakes or other high-calorie liquids, they may not lose a lot of weight.

If you are considering gastric banding, it is important that you read the information booklet provided by your surgeon and discuss any questions you have with your surgeon before deciding to have surgery. If your surgeon does not provide you with a booklet, ask for one.

FDA – 2011 Warning Letters

As part of its inspection, compliance enforcement and criminal investigation activities, the U.S. Food and Drug Administration (FDA) issues warning letters to businesses under its jurisdiction.  These letter  indicate violations based on the agency’s evaluation.

It is helpful to have access to a database of these communications, particularly as they may have information pertinent to your own business.

The FDA recently released a link to its compilation of warning letters covering over a 10-year period.  Click on this link to see the list and access the full content of the letters: 2011 Warning Letters.

Antibiotic Resistance – A Public Health Issue

According to the U.S. Food and Drug Administration (FDA), antibiotic resistance is a growing public health concern worldwide.

 

Antibiotics, also known as antimicrobial drugs, are drugs used for treating infections caused by bacteria. They have saved countless lives.  However, misuse and overuse of these drugs have contributed to a phenomenon known as antibiotic resistance. This resistance develops when potentially harmful bacteria change in a way that reduces or eliminates the effectiveness of antibiotics.

 

When a person is infected with an antibiotic-resistant bacterium, not only is treatment of that patient more difficult, but the antibiotic-resistant bacterium may spread to other people.

 

When antibiotics don’t work, the result can be

 

•          longer illnesses
•          more complicated illnesses
•          more doctor visits
•          the use of stronger and more expensive drugs
•          more deaths caused by bacterial infections

 

Examples of the types of bacteria that have become resistant to antibiotics include the species that cause skin infections, meningitis, sexually transmitted diseases and respiratory tract infections such as pneumonia.

 

In cooperation with other government agencies, the FDA has launched several initiatives to address antibiotic resistance.

 

The agency recently released a publication with helpful information – just in time for this season with potentially higher incidence of infections.

 

CLICK HERE to get a copy and related information – and pass it on.