The Best of 2012, A Year In Review

Mark SadakaThoughts%s Comments

This is the perfect time to take a look back at the year that has come to an end and feel gratitude for all the good fortune that has come my way. Each year since I started my firm the blessings continue to flow. Before We Start…. THANK YOU I would like to thank my wonderful team. I could not accomplish … Read More

Oregon Court Allows 510K Application Into Evidence

Mark SadakaLaw & Legal News, Product Liability%s Comments

We take a look at the admissibility of FDA 510(k) application in a medical device product liability case.  Case:  McClellan v. I-Flow, Inc., 2010 WL 3954092 (Dist. Ct. 2010) (U.S. District Court of Oregon) Plaintiff filed a Motion to Admit Newly Discovered Evidence to introduce documents received from the FDA in response to a FOIA request for the regulatory … Read More

States To J&J: Off-Label Promotion Is Off-Limits

Mark SadakaFDA & Drug Companies%s Comments

J&J recently settled with 36 states over claims that it marketed the antipsychotic drug Risperdal for unapproved uses (a/k/a Off-Label). J&J agreed to pay $181 million to the states. What is interesting about this settlement is that one provision, for the first time ever, restricts the way J&J markets their antipsychotics. J&J agreed to not distribute reprints of peer-reviewed scientific … Read More

The Role Of The FDA In Drug Approval

Mark SadakaConsumer News, FDA & Drug Companies%s Comments

What does it mean when a drug is FDA approved? It means that a drug is safe and effective for use. The primary role of the FDA is to ensure that prescription drugs and medical devices are safe and effective. The FDA determines the safety and efficacy of a product by reviewing the results of clinical trials. The FDA Doesn’t … Read More

What’s The Deal With BPA In Baby Bottles?

Mark SadakaConsumer News%s Comments

The chemical BPA is leeching into our food and poisoning our babies! Run! Hide! BPA is everywhere. The FDA finally made the decision to ban the chemical from baby bottles joining the European Union and Canada. But what is BPA? Is it really a risk to our health? What Is BPA? BPA is a chemical used to make plastics. Water … Read More

Big Pharma’s New 10 Point Credibility Initiative Isn’t Enough

Mark SadakaFDA & Drug Companies%s Comments

Let’s face it: the pharmaceutical industry has a credibility gap.  In a recent article, Mayo Clinic Proceedings, they even admit that the credibility of industry-funded research has suffered greatly in recent years.  The article’s authors outline 10 recommendations to repair the reputation of industry-funded research. Transparency is the clear focus of the recommendations.  The general theme is to empower physicians and other scientists … Read More

Drug Sales Down? Change The Disease

Mark SadakaConsumer News%s Comments

The definition of addiction is getting a re-write in the Diagnostic and Statistical Manual of Mental Disorders (“DSM”). This change would result in coverage for treatment of these illnesses by Medicaid, Medicare and other health insurers. While some of the changes are welcome, such as recognizing that gambling is an addiction, there are those that are suspect. There is discussion … Read More