Tag: FDA

John Oliver opened the second season of HBO’s “This Week Tonight” with a humorous but sobering segment on how big pharmaceutical companies market their drugs to doctors, spending an estimated $24 billion per year in direct marketing.  In his witty but serious way, he explains that 70% of Americans take at least one prescription drug, and spent $329 billion, $1000 per person, on those medications in 2013. John quipped, “Walter White could have made more money cooking up rheumatoid arthritis medication.”

Big Pharma tactics include everything from lunch, to sexy sales reps to expensive dinners with other doctors who pitch the sale as “thought leaders.” The drugs are often pushed for “off label” use, that is, use that the FDA has not approved and most of the reps know very little, if anything, about the drugs that they’re pushing.

Drug companies are like high school boyfriends, they’re more interested in getting inside you than in being effective once they are there.

One a the good things that the Affordable Care Act did is it created a web site, OpenPaymentsData.CMS.gov that which enables average citizens a chance to search for perks given to doctors by pharmaceutical companies.

FOR IMMEDIATE RELEASE – May 25, 2012 – This is to inform you of a product recall involving:

All Sterile Human and Veterinary Prescriptions Distributed by Franck’s Pharmacy From November 21, 2011 to May 21, 2012.

This recall is being initiated after the U.S. Food and Drug Administration (“FDA”) notified us that environmental sampling of our clean room revealed the presence of microorganisms and fungal growth. In light of the FDA’s findings and the resulting possible risk of infection, we have decided that it is imperative that we recall all human and veterinary sterile preparations that have left our control. Accordingly, we are extending the recall to all sterile preparations we have provided to you since November 21, 2011.

If any of these sterile preparations remains under your control, it is essential that you do not use them and that employing appropriate practices, you destroy all such sterile preparations and all remaining portions of such sterile preparations.

This recall should be carried out to the User/Physician level. Your assistance is appreciated and necessary to prevent patient illness. Physicians should be advised to review and evaluate their patient records to determine if any adverse events may have resulted from use of the recalled products. Please report any adverse events to Franck’s Compounding Pharmacy and FDA’s MedWatch program.

FDA will expect us to be able to account for all of the sterile preparations subject to this recall. As a result, it is critically important that you read, complete, and return the enclosed response form as soon as possible.

We will update you with any relevant details as they become available to us. If you have any questions please call us at 352-690-6773, Monday through Friday from 9AM to 5 PM, EST.

This recall is being made with the knowledge of the Food and Drug Administration.

After the food contamination incidents over the past couple of years, the Congress has put forth a revamp of food safety law in the United States.  This bill bass the House back in 2009 and was tied up in the Senate until last week.  The Senate passed its version (with amendments) and so it has gone back to the House for either passage of the Senate version or to head for a conference committee for resolution.

This act (S. 510) has created an outcry from both the extreme right and some “back to nature” types on the left.  Herein we shall examine some of the key provisions of the proposed law and make some judgments.  My personal feeling is that it will die before the Congress completes action on other, critical legislation like the tax issue, unemployment benefits, the federal debt ceiling, and funding the government, but who knows?

I have done quite a bit of research on this legislation and find it, for the most part, a pretty good thing.  It is designed to be proactive in that it stresses prevention of the production and distribution of contaminated or adulterated food rather than just merely reacting to an event after it occurs.  Certainly, there are reactive provisions as well, but prevention is the primary focus.

The legislation specifically applies to the following operations (from the summary posted http://www.govtrack.us/congress/bill… (This is from Title I [Improving Capacity to Prevent Food Safety Problems] of the bill):

…each person (excluding farms and restaurants) who manufactures, processes, packs, distributes, receives, holds, or imports an article of food permit inspection of his or her records if the Secretary believes that there is a reasonable probability that the use of or exposure to such food will cause serious adverse health consequences or death.

Note that farms and restaurants are specifically exempted.  This becomes important later.  There is also a part that delays implementation for small businesses until a later date, the specifics of which I have not been able to find.  It is a long bill.  Each operation specified above has to pay a $500 annual registration fee and comply with the recordkeeping requirements.  The thrust of the bill is to require such establishments to conduct proper hazards analyses and implement controls to reduce the probability that contamination or adulteration will occur.