Compounding Pharmacies – Good or Bad?

Compounding pharmacies are no longer serving their original purpose and can potentially be causing more harm than good.  Compounding pharmacies originally converted pills into a liquid form of medicine for individuals who could not swallow pills.  Now, some compounding pharmacies manufacturer prescription drugs in mass quantities and have been tied to outbreaks such as the fungal meningitis outbreak in 2012. There are thirty compounding pharmacies in eighteen states in the United States.  A House subcommittee is holding a hearing on April 16, 2013, to determine…
Continue reading...

A Potential Godsend to Mothers-to-Be

After a 30-year hiatus, the Food and Drug Administration (FDA) has once again approved a drug to specifically treat morning sickness.  Diclegis, made by Canadian Duchesnay Inc., is scheduled to be available in June 2013.  Diclegis combines Vitamin B6 and antihistamine doxylamine in a time released formula to prevent nausea before it sets in. The same drug combination was marketed as Benedectin from the 1950’s to 1980’s.  Despite no conclusive medical evidence that it caused birth defects and court rulings in its favor, Merrell Dow…
Continue reading...

Medical Device Tax – What is It?

The medical device tax is a 2.3 percent excise tax on the sales price of taxable medical devices.  The tax applies to almost all FDA registered devices.  Those devices range from hip implants to tongue depressors.  The medical device tax has been compared to excise taxes on tobacco and alcohol products. Who is paying this tax? The manufacturer or importer, with limited exceptions.  Thus, companies are losing 2.3 percent off the top of their margins.  Commentators argue that the tax will thwart invention. Others argue…
Continue reading...

Food & Drug Administration – Only 113 Characters Left In the Tweet

The FDA is on its way to regulating social media and its use by pharmaceutical companies.  By July 2014, the FDA must publish its guidelines for social media use. The FDA is faced with issuing guidelines on the appropriateness of tweeting.  A 140 character tweet is likely not long enough to include all of the necessary information such as risks and side effects.  Thomas Abrams, director of the FDA’s Office of Prescription Drug Promotion supports pharmaceutical companies promoting their products on Twitter if they can…
Continue reading...

Tylenol Subject of Latest New Jersey Centralized Management Request

Suits alleging liver damage from acetaminophen are the latest subject of a request for centralized management in New Jersey.  Late last month, McNeil-PPC and Johnson & Johnson submitted an application seeking centralized management of all pending New Jersey lawsuits involving alleged liver damage from Tylenol products. The application, which comes on the heels of the establishment of a federal Multi-District Litigation for similar suits pending in the federal courts, seeks centralization of all New Jersey Tylenol cases in Middlesex County before Judge Mayer, rather than…
Continue reading...

House Republicans Question Supplement Companies about Ingredient Declared Illegal and Potentially Unsafe by FDA

Three members of the House of Representatives recently questioned multiple supplement companies about the continued sale of products containing DMAA (dimethylamylamine), a synthetic drug linked to several deaths. The Food and Drug Administration (FDA) has previously urged consumers to avoid products containing DMAA.  DMAA is an ingredient in some weight loss or muscle development supplements.  It is alleged that the drug could trigger heart problems.  The FDA has reportedly received over 80 reports linking supplements containing DMAA to injury, illness and death.  However,…
Continue reading...

Natural Product Claims Lead to Liability

On Tuesday, May 7, 2013, a proposed class action lawsuit was filed in the United States District Court for the Southern District of New York on behalf of plaintiff, Michael Goldenberg, and other similarly situated consumers, against Johnson & Johnson Consumer Companies, Inc. (“J&J”), alleging the consumer manufacturer mislead consumers about the nature of the ingredients in its personal care products sold under the Aveeno brand name (see, Goldenberg v. Johnson & Johnson, 7:13-cv-03073).  According to the Complaint, these products were marketed with…
Continue reading...

Attorneys Split Over Impact of FDA’s Plan to Increase Surveillance of Medical Device Complaints

The United States Food and Drug Administration (FDA) has announced further details in its plan to make it easier for physicians and patients to report problems with medical devices.  The plan includes the use of unique device identifiers in electronic health records and billing claims, and creation of a nationwide registry of devices.  The FDA also plans to use technology to make reporting adverse events, such as injury, easier by releasing the MedWatcher mobile app.  The app will allow physicians and users to file adverse…
Continue reading...

Reconsideration Sought for Multi-County Litigation Denial

Previously, we noted that the New Jersey Supreme Court denied an application by Bayer HealthCare Pharmaceuticals, Inc. for centralized management of all New Jersey claims involving the Mirena contraceptive device.  Currently, there is an application for reconsideration pending before the New Jersey Supreme Court, again seeking designation of this growing litigation as a Multi-County Litigation.  However, while both Bayer and plaintiffs have sought reconsideration — and thus appear to agree that centralization is appropriate — the sides may differ on where they want that…
Continue reading...

Report Links Some Dietary Supplements to Potentially High Arsenic Levels

In a recent article published in Analytical & Bioanalytical Chemistry, author Rikke Hedegaard and colleagues state that “consumption of certain dietary supplements could contribute significantly to the dietary exposure to inorganic arsenic at levels close to the toxicological limits established by [the] European Food Safety Authority (EFSA).”  The article, entitled Total and inorganic arsenic in dietary supplements based on herbs, other botanicals and algae – a possible contributor to inorganic arsenic exposure, is an example of scientific developments that dietary supplement companies need…
Continue reading...