a side note

It's no secret the FDA is strict. They are a stickler on anything and everything "drug" related. Take my family friend's business for example. They own and operate a small wholesale and distribution center in Los Angeles. Working mainly with export, they contact pharmaceutical companies in the United States, purchase their merchandise and export it to countries seeking U.S. medicine. After all U.S. medicine is considered of very high quality. 

Why is that you ask? It's because we have the FDA.

The FDA periodically comes and checks that the warehouse is following protocol - from warehouse security to air conditioning, small business owners working with medicine is under immense security and can be cited for minute details. It is because of this that U.S. medicine has a reputation for quality and value. 

But on a side note, lets not forget the FDA is also in charge of all agricultural products in the U.S. Whether foods are imported or grown in backyards, foods that are sold to the public are under FDA jurisdiction. 

Consequently, with the hundreds to thousands of business in the food industry, some are likely to fail the inspection. Last week it was the Sun Hong Kai Holding Inc. of Atlanta. In their "Public Health Regulatory Inspection," the FDA seized over "$700,000 in rice and food packages." It seems the food was not stored or held properly and could perish. 

Interesting enough, the FDA is actually currently understaffed and has been struggling with their legal duties. Regardless of such, it is evident they can still perform optimally - ensuring the health of the American people by cracking down on the agricultural corporations that are not following the rules.


Good to know they have my best interest at heart.

-J 

admittedly we were wrong.

You are one lucky individual to witness this historic event. Although they never actually used the words "we were wrong," the FDA has also never revoked approval on a product they had already pushed to the market. 

Menaflex, a knee patch by ReGen Biologics, was FDA approved in 2008. The product had already been thriving in Europe for several years and administered to over 3,000 knee implant patients. Thus the FDA was inclined to push the product without thoroughly testing the device. 

"We are concluding that the science does not support a decision to clear the device, and therefore we’ll move forward to rescind” its approval, Dr. Jeffrey E. Shuren, director of the FDA’s device center reported.

The FDA has never admitted they were wrong for approving a drug or medical product. They also never rescinded approval two years after a product has circulated in the market. But pressures from a group of FDA medical officials caused the FDA to revisit the approval. They argued that politics unmistakably trumped the science. 

But honestly, I could care less about the knee patch. I am worried about all the other drugs that are currently on the market because they were approved out of "politics."  When political pressures sets in I want to know that the FDA is still holding its ground and not succumbing to the harassment. 

I recently saw a documentary by PBS Frontline on the emergence of AIDS. With the initial discovery of AIDS politicians were reluctant to spearhead campaigns to fight AIDS and encourage patient education due to the stigma attached to the illness. And when drug companies began finding antiretroviral drugs, ART, to combat against the HIV virus that caused AIDS, the FDA was under immense pressure to approve the drug. When millions of people are dying from an incurable virus the FDA better not let "politics" be a determining factor for drug approval. I wouldn't want millions more to die because politics trumped science. 

There is too much at stake. 

-J

soulmate

I've found my other half - the one person who knows what I'm thinking even before I think it, and has a habit of finishing my sentences, so to speak. 

PredictER. He is everything I can hope for in a social bookmarking soulmate. He tags articles I would have tagged myself, but is twice as efficient. With over 300 tags on the FDA, medical ethics, drug trials, patient awareness, and health profession, his tag cloud is more than I can ever hope for. The best part is PredictER has a habit of tagging scholarly articles which saves me the trouble of investigating credible sources. Although his comments are minimal I can tell where his line of thinking follows. The reality of it is I am PredictER's social bookmarking soulmate. We're made for each other. 

From genomics to public policy, PredictER has tagged several articles pertaining to patient education and awareness. It seems he has found evidence to support the claim that patients are not participating in diagnosis and treatment - merely ignorantly following the orders of doctors. This behavior is detrimental.

One of the articles tagged describes patients who enter genetic screening trials without fully understanding the possible repercussions of their actions. Genetic screening is opening doors to a new breed of ethics. With genetics, familial ties and illnesses are just some pieces of information that become known. What happens when a child finds out that the person he/she has always called "Dad" is not really their biological father? Or if a child inherits an incurable disease from a single parent? This type of information has the ability to break up families. Ultimately, the article stems around patient's lack of understanding and awareness of their actions. Genetic screening is not to be taken lightly.

Another article touches upon the continuing efforts of the FDA to push forth new drugs even when the clinical trials do not produce the most promising results. Again, more ethics, more issues, more crap from the FDA.

Nevertheless, PredictER has made my life simpler. He is truly my bookmarking soulmate. The only one out there. 

-J

i will comment as i please.

To: Pharma Marketing

I've never considered the consequences resulting from disease awareness or support campaigns. If what you say is true, that “with each live saved by a mammogram- five to fifteen other women become needlessly diagnosed”, then my concern won't be limited to the month of October during Breast Cancer awareness, but every month of the year. If you haven't noticed, there is a month set aside for almost every kind of illness. Aids awareness is the month of December, Lupus during the month of May, and TB during the month of March just to name a few.

Does that mean that with each passing month, hundreds to thousands of patients are doomed to be needlessly or incorrectly diagnosed? Not only is the government wasting valuable resources for those who actually require screening, it does more harm than good to patients. If that’s the case a new approach to patient education and awareness is critical. In spite of this, I don’t mean to stop fighting for the cause all together because I myself have family and friends who benefit greatly from the month of October. The funds raised are incredible and really helps to lift their spirits.  But these campaigns need to be regulated and the media needs to take on the responsibility of informing the public that the month of October shouldn’t be a month of looking for the illness, but instead fighting it.

-J

To: Eye on FDA

I’ve only just entered the pharma industry – focusing more on the pharm and less on the industry. But I couldn’t help reading after I saw the words Twitter. It’s interesting to see that pharma companies are entering this new age of technological advancement where social media has completely changed the normal avenues of communication. What ever happened to email and phone calls? “Twitter feeds” and “Retwittering” is just a bizarre concept for companies as regulated and strict as pharmaceutical companies and the FDA.

But I understand how the media and public relations department of pharma co. can reap the benefits of using twitter. It is probably the fastest way to get information out allowing for an endless list of “followers.” Yet some may argue, informal and unprofessional. Nevertheless, I would be interested in following FDARecalls myself and ask all my colleagues to follow as well. Who knows, maybe we’ll find it innovate and start our own. 

-J