FDA

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There's lots of confusion over the availability of generic OxyContin (oxycodone)now that the patent for the original form of the drug expired on April 16, 2013. It does not appear that generic versions will be available soon however. Beware of online "pharmacies" advertising generic oxycodone availability. They are usually fakes or substandard versions.More »

I was watching television the other night when I came across a certain type of commercial with which I’m sure you are all familiar. Ominous pill bottles and dark, shadowy backgrounds emerge followed by a rapid voiceover announcing that a certain drug has been linked to [insert any number of alarming medical conditions]. Then a toll-free number for some distant law firm, recruiting the public to participate in a class-action lawsuit, appears and the commercial ends. I won’t pretend to know how these attempts pan out, nor do I plan to research the topic. Instead, the focus of this post is to explore the pharmaceutical industry, the current public and professional opinion of it, and reasons both sides need to work to close the trust gap for the good of society.More »

Here is a blurb that comes from the FDLI news e-mail service (FDLI SmartBrief: fdli@smartbrief.com). The potential for delayed reviews is not the most interesting part. Its the multiple and various fee amounts that drug companies have to pay to the FDA to get a "New Drug Approval"(NDA). No wonder new drugs are so expensive (example: 30 days Abilify 5 mg over $700.00). It also makes me wonder how much "watchdog" function the FDA devotes to public safety when its funding comes primarily from the companies paying the fees. Fox watching the henhouse? Non issue? What do you think?More »

As the 2012 Presidential campaigns continue to heat up, there seems to be no shortage of Americans who would like to see less government intervention in our lives. What I don’t hear is just how much less and exactly what services should be cut. I get the feeling that many people who are quick to criticize various government agencies’ programs are okay with their elimination as long as it doesn’t affect them personally. I think it goes without saying that our government could stand to undergo a close inspection of all its programs and cut or reduce those that do not benefit the majority of Americans. I do think, however, that there are many significant and worthwhile government agencies and programs that warrant investing in as well. One of those is the FDA.More »

FDA

In the July issue of US Pharmacist, I wrote an article, "REMS: A New Duty for Pharmacists?," posted 7/20/2011, US Pharm. 2011;36(7):56-59, http://uspharmacist.com/content/d/pharmacy_law/c/29047/. On October 19, 2011 the FDA reopened the public commentary time through a notice posted in the Federal Register, Vol. 74; No. 200. This was in response to a published discussion by the FDA on "Opioid Drugs and Risk Evaluation and Mitigation Strategies (REMS): November 2009 Update," posted originally in September, 2010, http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm226958.htm. In November 2011, the FDA published "Guidance for Industry Medication Guides — Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS) DRAFT GUIDANCE," http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformati... that sets force the terms, conditions and exemptions for pharmacists to distribute the REMS patient packaging labels.

It would be worthwhile for pharmacists to take the time to read through this Guidance to make sure you are in compliance when dispensing REMS designated medications.More »

FDA, Guidance, REMS

At least four or five of my monthly columns in US Pharmacist have focused on the two decades worth of actions taken against compounding pharmacies and pharmacists claiming the compounding activity is really manufacturing and requires an FDA license. The pharmacies and pharmacists almost always win. Even the Supreme Court has ruled pharmacists are allowed to compound. But the FDA just doesn't get it. They just keep on persecuting (I do mean persecuting, not just prosecuting) compounders.More »

Finally, after years of advocacy by many pharmacist-lawyers and pharmacy law teachers (see http://www.aspl.org/), the FDA may be on the brink of actually recognizing that there are special considerations that must be taken into account when doing generic interchange (drug substitution) for a brand-name that is considered to be a Narrow Therapeutic Index (NTI)drug. The ASHP Newslink on August 16, 2011 (http://www.ashp.org/menu/News/PharmacyNews/NewsArticle.aspx?id=3593, reported "Advisers to FDA overwhelmingly supported the agency’s first steps toward establishing new standards to assess the bioequivalence of generic and innovator drugs that have what is known as a narrow therapeutic index." Read the whole article for more details.

I am concerned that it may only be a matter of time before somebody sues a pharmacy or pharmacist for doing an NTI drug substitution and can show harm as a result. Please use extra care when engaging in this specific activity.More »

Here is a list of dietary supplement resources where you can find information, alerts and safety information on dietary supplements:

www.naturalmedicines.comMore »

1/13/2010 10:16:00 AM

WASHINGTON—FDA released FDA Basics, a consumer Web site directed at explaining agency operations, how it makes decisions and the drug approval process. In a press release, FDA said this is the first phase of its Transparency Initiative.

The new Web-based curriculum includes: questions and answers about the agency and the products it regulates, short videos that explain various agency activities and conversations with agency personnel about the work of their office. According to FDA, senior officials from FDA product centers and offices will answer questions on various topics during future online sessions.More »

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