Health Care Law Matters

Here is our monthly summary of selected FDA Warning Letters recently made public by FDA. The statistics for this report: 

- 24 letters re cGMP device violations; 

- 9 letters re medical device reporting (Animas Corporation (including cGMP violations), Health Science Products, Incorporated (including cGMP violations), APC Medical Limited (including cGMP and registration and listing violations), Teh Lin Prosthetic & Orthopedic, Inc. (including cGMP violations), Sorin Group Deutschland GmbH (including cGMP violations), The Lasik Vision Institute, Newman Lasik Centers LLC, Soring Medical Technology (including cGMP violations) and Okamoto Industries Inc. (including cGMP violations)); 

- 7 letters re cGMP pharma violations;

- 6 letters re unapproved new drugs (Herbal Extracts Plus, LLC, Agora Publishing Inc., Natural Health Team, The hCG Drops LLC, Mushroom Wisdom, Inc., and BioAnue Laboratories, Inc.);

- 3 letters re unapproved new use of devices (Medical Quant USA (including cGMP violations), Merit Medical Ireland Ltd. and BioElectronics Corporation);

- 2 letters re unapproved new devices (Akers Biosciences, Inc., and Spencer Forrest, Inc.);

- 2 letters re tobacco product marketing and sales (The Pinkerton Tobacco Company and Tobacco Source Three LLC);  

- 1 letter re an unapproved new OTC homeopathic (Schwabe North America, Inc.);

- 1 letter re an unapproved new dietary supplement (Almased USA, Inc.);

- 1 letter re unapproved new use of an OTC device (CuraeLase, Inc. (including cGMP and MDR violations));

- 1 letter re drug study violations (Betty Tuller, Ph.D.); and

- 1 letter re import for export (MedPharm, LLC). 

And of particular note:

• FDA cited one manufacturer of drug components and its immediate shipper for violation of Import for Export provisions because of failure to provide IFE records and a report, despite multiple requests by FDA.
• FDA issued a warning letter to one company for promoting unapproved new drugs that made unsubstantiated claims about treatment of a wide variety of conditions, including cancer, autism, schizophrenia, multiple sclerosis, hepatitis C, and HIV infection.
• FDA cited another company for making unsubstantiated therapeutic claims, including treatment of cancer and Alzheimer’s disease, about its mushroom supplements that FDA considered unapproved new drugs.  In addition to inclusion of these claims on the company’s website, they were also supplemented by metatags used to bring consumers to the site.
• FDA issued a warning letter to the manufacturer of a laser system for the unapproved new use of a device, as well as violation of Electronic Product Radiation Control requirements because of failure to submit product reports and file its annual report.
• FDA also cited a tobacco company for violating the agency’s regulations restricting the sale and distribution of tobacco products to minors by promoting its “No Nonsense Rewards” program, wherein customers were offered a check in exchange for providing proof of purchase of specially marked packages of the company’s moist snuff product.
• FDA continues to focus on Good Manufacturing Practices and posted warning letters for the following devices: steam sterilizers, an anti-embolism wrap system, lower limb prosthetics, bone densitometers, anesthetic delivery systems and respiratory therapy equipment, contact lenses, external penile rigidity devices, infusion pumps and urological catheters, neurosurgery and hemostatic devices, wound and burn dressings, temperature indicators, dental prosthetics, plasma coagulation control devices, an enteral infusion pumps, sterile syringes, an orthogonal percussion adjusting instrument, a turning medical bed, a pharmaceutical compounding device, telemetry devices, electrocardiogram monitoring equipment and software devices, a non-sterile blood pressure monitor, a total knee replacement system, a ventricular assist system, and a powered muscle stimulator device.  In addition to the cGMP violations, FDA cited twelve companies for MDR violations, two for unapproved devices, two for unapproved new uses of a device, one for Report of Corrections and Removal violations, and two for Registration and Listing violations.  
• FDA also posted seven warning letter for cGMP violations regarding finished pharmaceuticals and dietary supplements.  In addition to the cGMP violations, FDA cited one company for labeling violations, and one company for unapproved new drugs and field alert report violations.

Here is a summary of selected warning letters that FDA posted during the month of July, the most recent complete month available.  GMP remains the most frequently cited enforcement issue for the agency.  Of particular note:

• FDA issued a warning letter to one company for marketing a hair loss prevention product, an acne drug product and weight loss aid products, all of which FDA considered unapproved new drugs.  With regard to the weight loss products, FDA noted that they contained sibutramine, an active pharmaceutical ingredient used in Meridia, a new drug manufactured by Abbott Laboratories and approved by FDA for prescription treatment of obesity and subsequently withdrawn from the U.S. market after clinical data indicated an increased risk of heart attack and stroke. 
• FDA also issued another warning letter for unapproved new drugs, citing one company for therapeutic claims that the effect of its flaxseed products was similar to the breast cancer drug, Tamoxifen.
• FDA cited a company for new use of an OTC hydrophilic wound device that would ordinarily be exempt from premarket notification, but in this case the product exceeded the exemption limitations because it contained potassium ferrate which functions as a drug.
• FDA issued a warning letter to a specification developer and distributor of a personal lubricant and a condom in combination with the lubricant regarding a new use of the device.  Although the condom was previously cleared with a different lubricant, the company’s change of lubricant constituted a major change from the specifications and intended uses filed with FDA in a previously obtained 510(k) clearance.
• As part of its Bioresearch Monitoring Program, FDA cited two physicians for GCP violations involving drug studies.
• FDA also cited a company for dietary supplement labeling violations of its “muscle milk” nutritional shakes.
• Two warning letters were issued by FDA for tobacco product violations: one for modified risk claims and the other for flavored tobacco.
• In addition, FDA cited two companies for violations involving human cells, tissues, and cellular and tissue-based products (HCT/P), donor testing and donor screening.
• FDA continues to focus on Good Manufacturing Practices and posted warning letters for the following devices:  automated external defibrillators, medical device replacement batteries, sterile, single-use, ophthalmic surgical kits and blades, blood screening test devices, an isolation chamber and ambulance transport isolation system, bassinets, otoscope specula and electrogel products.  In addition to the cGMP violations, FDA cited four companies for registration and listing violations, two for MDR violations and two for unapproved devices.  FDA also posted warning letters for finished pharmaceuticals and dietary supplements. 

The statistics are:

• 9 letters re cGMP device violations;
• 5 letters re cGMP pharma violations;
• 2 letters re unapproved new use of a device (Mayer Laboratories, Inc. and Vertiflex, Inc. (including MDR and cGMP violations));
• 2 letters re drug studies (Joseph B. Michelson, M.D. and Linda D. Bosserman, M.D.);
• 2 letters re tobacco products (Belcorp of America and Wayan Sumartini Saraswati); 
• 2 letters re HCT/P donor testing and screening (Advanced Fertility Group, PC and Seattle Sperm Bank, LLC);
• 1 letter re an unapproved new drug (Premium Gold Flax Products & Processing, Inc.);
• 1 letter re an unapproved new OTC drug and dietary supplement (Shaping Beauty, Inc.);
• 1 letter re an unapproved new OTC drug/new use of a device (BioLife, LLC);
• 1 letter re dietary supplement labeling (CytoSport, Inc.); and
• 1 letter re mammography quality standards (Redwood Memorial Hospital).

Contributed by Kimberly K. Egan and Rebecca Jones McKnight as part of our ongoing Warning Letters Matter series.

FDA posted warning letters for some unusual products in April. FDA cited manufacturers for violations involving organic bean sprouts as unapproved new drugs, as well as a dietary supplement being marketed as a Viagra-replacement and for prevention of prostate cancer. In addition, FDA cited two companies for making unsubstantiated therapeutic claims, one involving a dietary supplement and the other involving different types of mushrooms, in connection with cancer prevention and treatment of other effects of radiation exposure secondary to the earthquake in Japan.

FDA posted four warning letters to companies marketing devices that the companies had meaningfully changed from the specifications and intended uses filed with FDA in previously obtained 510(k) clearance. The devices included a thermal imaging system, a hemodialysis blood tubing set, a needle-type epilator device, and a laser hair removal device.

FDA continues to focus on Good Manufacturing Practices, and posted warning letters for automated blood cell separators and disposable collection sets, surgical sutures, defibrillators, and soy dietary supplement drinks. FDA also cited a Chinese manufacturer for GMP violations involving unidentified Active Pharmaceutical Ingredients.

The statistics are:

3 letters re cGMP device violations;

3 letters re unapproved new use of devices (Meditherm, Fresenius SE/Fresenius Medical Care Holdings, Inc., and Refine USA, LLC);

3 letters re unapproved new drugs/dietary supplements (Saw Palmetto Harvesting Co., Omega Nutrition USA Inc. (including cGMP violations) and Diaspora Tea & Herb Co., LLC);

2 letters re cGMP pharma violations;

2 letters re food products as new drugs (Jonathan’s Sprouts, Inc. and Eidon Incorporated);

1 letter re promotional activities (Three Rivers Pharmaceuticals, LLC); and

1 letter re unapproved device/pending OTC clearance (BNB Medical Co., Ltd.);

Contributed by Kimberly K. Egan and Rebecca Jones McKnight as part of our ongoing Warning Letters Matter series.

In February, FDA issued five warning letters in connection with unapproved new drugs with unsubstantiated therapeutic claims in their promotional materials. Companies were marketing all five of these products as dietary supplements. Of note, FDA included reference to FTC violations in its letter to one of these companies, Tennessee Scientific, Inc./Scientific Formulations LLC.

FDA also issued seven warning letters to companies marketing and distributing unapproved medical devices, five of which involved companies marketing devices that the companies had meaningfully changed from the specifications and intended uses filed with FDA in previously obtaining 510(k) clearance.

The statistics are:

• 16 letters re GMP violations;
• 7 letters re unapproved devices (Syneron, Inc. (including cGMP violations), Angiodynamics, Inc., Inno Health Technology, Inc., Medicepts, Inc. (including cGMP violations), Fresenius SE, Steris Corporation and Bioptigen Inc.);
• 5 letters re unapproved new drugs/dietary supplements (Living Naturally, NutriHerb, Inc., Natural Options Corp., Tennessee Scientific, Inc./Scientific Formulations LLC (including FTC violations) and LimpiaArteria);
• 2 letters re drug study institutional review boards (Marquette General Health System IRB and Napoli LLC);
• 1 letter re a clinical investigation sponsor (Anulex Technologies, Inc.);
• 1 letter re postmarketing adverse drug experience reporting (Sanofi Aventis U.S. LLC).