Compliance Resources to Help you Stay Current

An original drug manufacturer seeking new drug approval from the FDA is responsible for accurately and adequately labeling the new drug. A manufacturer of a generic drug is only responsible for making sure its warning label is the same as the reference drug. This has led to an outcry from patients and drug manufacturers as generics makers cannot be held legally responsible for any product defects. Both groups are demanding a change in current generics warning label regulations by the FDA.

On Feb 28 2012, the FDA released new draft guidance on safety changes for widely used cholesterol – lowering or statin drugs. These regulations aim to educate, update health care professionals and patients about the health benefits as well as risks associated with these drugs.

In Australia, advertisements for therapeutic goods that are directed at consumers should get approved before broadcasting or publication and must comply with Therapeutic Goods Advertising Code.

This article gives an overview and summary of requirements of the code.

In October 2011, the FDA issued final guidance on Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Prescription Drugs and Biological Products. The aim of the guidance is to help ensure that labeling is clear, useful, informative, and to the extent possible, consistent in content and format.

This article gives a brief overview and summary of the recommendations contained in the guidance.
 

An ePedigree or electronic pedigree is an electronic document that satisfies pedigree requirements of prescription drugs. While the FDA hasn’t implemented ePedigree specific regulations for the pharmaceutical supply chain, California has formulated laws regarding the use of ePedigrees.

This article describes the background to ePedigrees, current regulations governing their use and implementation status.

The Fair Packaging and Labeling Act (FPLA) of 1966 was enacted to ensure that customers are provided enough information to choose wisely among competing products. The Act is enforced by both the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC).

This article describes the background to the act, summary of its provisions and recent amendments.

The European General Product Safety Directive (2001/95/EC) directive covers nearly all products sold in the European Union. It places responsibility on suppliers of consumer goods to make sure their products are safe for normal and foreseeable use. The directive also requires producers to supply consumers with relevant information that enables them to assess the risks inherent in that product.

This directive covers nearly all products sold in the European Union. In general, it places responsibility on suppliers of consumer goods to make sure their products are safe for normal and foreseeable use. The directive also requires producers to supply consumers with relevant information that enables them to assess the risks inherent in that product. It takes into account various characteristics including pack-aging/labeling, instructions for use and disposal, packaging, maintenance and more.

Zonegran is an FDA approved anti-epileptic drug, manufactured by the Irish company, Elan Corporation PLC. However, Elan and its U.S subsidiary promoted Zonegran for a variety of improper uses, including mood stabilization, migraine headaches, eating disorders and weight loss. It amounted to illegal promotion of the drug.  The Justice Department slapped a fine of USD 203 million plus on Elan Corporation PLC and its U.S. subsidiary under the False Claims Act. The Japanese drug marketer Eisai Inc., which bought the drug from Elan, will pay USD 11 million for off-label marketing of Zonegran.

Elan has consented to plead guilty and pay a criminal fine of USD 97 million and an additional USD 102.3 million to resolve civil allegations. It will forfeit assets worth USD 3.6 million too. The settlement demonstrates the government's determination to curb health care frauds by invoking the False Claims Act. The Justice Department claims to have recovered USD 5 billion plus since January 2009 in cases involving fraud against federal health care programs alone.

Regulations

The False Claims Act (31 U.S.C. § 3729–3733, also called the "Lincoln Law") is an American federal law that allows civilians to file complaints against federal contractors for filing fraudulent claims against the government. The act of filing such complaints is informally called "whistleblowing." Individuals filing under the Act stand to receive a portion (usually 15 to 25%) of any recovered damages. The Act provides a legal tool to counteract fraudulent billings turned in to the federal government. Claims under the law have been filed by persons with insider knowledge of false claims involving health care, military, or other government spending programs. The government has recovered nearly USD 22 billion under the False Claims Act between 1987 and 2008.

Source:  

http://www.pharmpro.com/news/2010/12/business-Elan-to-Pay-203M-Off-Label-Marketing-Fine/

http://en.wikipedia.org/wiki/False_Claims_Act

The U.S. Environmental Protection Agency (EPA) levied a fine of USD 82,400 on Monterey Park, Calif.- based Kinetic Solutions Inc., for allegedly selling unregistered and misbranded pesticides. The company made illegal public health claims for its air purifier branded “Nano Silver Pre filter” and the filter’s ability to control over 650 types of bacteria. It also claimed that its filter incorporated a substance called "nano silver" or "silver nano ions,” which prevent, destroy, repel or mitigate bacteria and mold. Law defines products that kill or repel bacteria or germs as pesticides, and hence they must be registered with the EPA before distribution or sale. EPA does not register a pesticide until it has been tested to demonstrate that it will not pose an unreasonable risk when used according to the directions. According to EPA, the Nano Silver Pre Filter was marketed as a pesticide although it was not registered as such. Thus, the company’s false claim and failure to comply with the federal law violated the Federal Insecticide, Fungicide, and Rodenticide Act. The violations were discovered through an online search and subsequent inspection by the California Department of Pesticide Regulation.

A new Canadian law came into effect after receiving the Royal Assent - the Canada Consumer Product Safety Act (CCPSA). The federal Minister of Health, Honorable Leona Aglukkaq stated, "I am delighted our Government's Consumer Product Safety Act is now the law of the land," said Minister Aglukkaq. "This will give the Harper Government important new tools to deliver stronger, more effective protection for Canadian consumers and their families."

Brinkman Turkey Farms Inc. of Findlay, Ohio, recalled Brinkman's Gourmet Barbecue Sauce Jars (22 oz, 40 oz, 160 oz) bearing the codes, UPC# 033244000215,UPC# 033244000222 and UPC# 033244000208 from distribution. These products were distributed to retail stores, distribution centers and consumers in Ohio, Wisconsin, Michigan, Illinois, and Iowa. The recall was initiated because the product contained milk and soy distributed in packaging that did not reveal the presence of these ingredients. Milk and soy can cause serious to life-threatening reactions in individuals allergic to them.

Two separate natural health products (NHPs) are being recalled from the Canadian market. These products, Probiophilus and Cultures de Yogourt 5 Milliards, labeled non-dairy, are being voluntarily recalled by Les Importations Herbasanté Inc. and Bio-Dis Inc respectively.

California Firm, Diana’s Mexican Food Products, Inc. has announced the recall of around 41,670 pounds of chicken tamales. The recall was triggered due to the presence of an undeclared allergen, whey. The company had not declared the same on the label.

McCormick & Company, Incorporated (NYSE:MKC), with the knowledge of the Food and Drug Administration (FDA), has issued a voluntary recall of Golden Dipt® Fry Easy All-Purpose Batter, 10 OZ, having the UPC Code 4123470111 and to be used by NOV 17 11 AH as a limited number of packages of the product possessing this date code are said to contain an egg ingredient which does not show on its label.

FDA issued warning letter to Nestle USA for observed violations under misleading labeling found on their Juicy Juice Products. FDA has observed that the labeling on the product is in violation of section 403(r) of the Act [21 USC 343(r)] and 21 CFR 101, 105 and 107. The labeling includes nutrient content claims which is not allowed or a food intended for use by infants and children less than 2 years of age. This is a case of misbranding of products as per FDA.

USP has come out with a revised standard for labelling of ferrules and cap overseals of injectable drugs. This move has been made to help end users to see critical safety messages. The standard enforces the printing of safety messages on ferrules and cap overseals except were the message is clearly visible and has a visible contrast against the transparent cap overseal whichis legible under normal conditions of use. The standard restricts the location of other less important information which should be placed such a way that they don't interfere with safety messages. USP has come up with this standard after consultation with medical, nursing, pharmacy workers, industry representatives and FDA officials.

A lot is seen, read and heard about environmental change and climate change owing to the abuse we humans have meted out. A great deal of effort is being put into awareness, so that people adopt environment friendly measures. People are smarting up to the idea and are adopting fast.

Manufacturers are vying hard to cash in on this trend as the research made by Nielsen BASES and NMI have forecasted promising statistics with regards to the market. The paper goes on to identify the key highlights for marketers to retain:

1. The stage is set for many consumer packaged goods (CPG) categories to go green.
2. Green doesn’t have to be niche.
3. Extending an established brand equity may be the best bet.
4. Green/LOHAS products have a better chance of breaking through the clutter.
5. Getting beyond “niche” will require choosing and attracting the right target.
6. Getting the price right is a clear key to success.

More on green marketing strategies