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While I spend most of my time as a freelancer, I sometimes will do contract work because the pay is good and the hours are reasonable. As many of you know by now, using contractors rather than hiring new employees has become the new way of controlling costs and keeping the full time headcount low. After all, paying someone an hour wage without covering insurance and other employee benefits costs can be huge savings to companies trying to maintain competitiveness and cut costs.

During my various stints as a contract employee, I learned that the rules governing the hiring of contractors vary widely from company to company and agency to agency. Consequently, there are a lot of myths, urban legends and misinformation regarding hiring contractors and the obligations of employers to them. Admittedly, I am a bit confused about the rules surrounding hiring and employing contractors despite the fact that I have been a contractor on more than three occasions. 

For those of you who may be confused as me or others who simply want to learn more about contracting, I highly recommend an article by Katherine Reynolds Lewis in the small business section of the NY Times entitled “Hiring Contractors Without Getting Into Trouble.”

The article offers a comprehensive overview of the Federal laws governing contractor hiring practices, the challenges of a contractor workforce and how to maximize the effectiveness of contract employees. Despite its obvious employer bias, it does paint a realistic view of what persons interested in contract work will likely encounter in the workplace.

Until next time....

Good Luck and Good Job Hunting!!!!!!!!!

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As I mentioned in a post about a month or so ago, the US Food and Drug Administration (FDA) floated a proposal to ease the rules regarding promotion of off-label use of previously approved drugs. According to the newly proposed rules, FDA would allow drug makers to provide physicians with reprints of journal articles that conspicuously promote off-label uses for previously approved products. At present, drug companies are strictly forbidden to promote off-label use of their products.  A major proviso of the proposed rule changes is that the articles/reprints must be published in peer reviewed medical journals before they can be disseminated to physicians and other healthcare professionals. Apparently, FDA officials believe that peer review can take the place of the rigorous regulations and requirements that are currently in place for US approval of drugs, biologics and medical devices!

For those of you who don’t know, an editorial appeared in last week’sJournal of the American Medical Association (JAMA) that took drug maker Merck to task for using alleged ghostwriters and ghost authors on clinical studies that were published about it painkiller Vioxx. As you all know, Merck voluntarily took Vioxx off the market in 2004 after it was revealed that the drug could lead to increased risk of heart attack and stroke.

The incendiary firestorm that has ensued since the appearance of the  Although I believe that the practices of ghostwriting and ghost authoring are not as widespread as the JAMA authors would like you to believe, I think that it is a good thing that FDA may scuttle its proposed new off-label drug promotion rules.

In my opinion (humble or otherwise), drug makers MUST be required to prove that off-label uses of previously approved products  don’t pose any serious safety or health risks before companies are allowed to promote them for new indications. As we have seen time and again in recent years, safety issues and serious health risks can arise for drugs even though they received FDA approval. With this in mind I ask: “Why would FDA allow drug makers to provide less rigorous proof for an off-label indication than that required for approval of the intended use of the original product?”  It makes little sense to me. However, looking more closely at the proposed rule changes,  it would obviate the need for companies to spend additional monies (possibly hundreds of millions) to garner FDA approval for a new product indication.  Hmmm….maybe I am beginning to see a pattern here!!!!!!!

Until next time….

Good Luck and Good Job Hunting!!!!!!!!!!!!

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