The Food and Drug Administration is going back at the patient insert industry (PI industry) that mainly involves pharmacists and other drug professionals. The newest proposal will require the elimination of the paper insert in lieu of putting it all on the internet. This does not include those areas where the patient/consumer receives the PI directly.
“The Food and Drug Administration (FDA or the Agency) is proposing to amend its prescription drug and biological product labeling regulations to require electronic distribution of the prescribing information intended for health care professional, which is currently distributed in paper form on or within the package from which a prescription drug or biological product is dispensed.” FDA is also proposing that prescribing information intended for health care professionals will no longer be permitted to be distributed in paper form with the package from which a prescription drug or biological product is dispensed except at provided by regulation. ” FDA-2007-N-0363
This proposal is pointed at those companies that manufacture PI’s which are often glued to the top of large bottles of medication. The “bulk” materials are often repackaged in smaller containers to be given to patients/consumers. (This is only about 4% of JH Bertrand’s business, but it is a very interesting story to us) The proposal is to require this information to be online only and to forbid it from being on the product package.
A year ago, this idea was part of a bill that was moving through the US Senate and House of Representatives. A few senators removed it from the bill (H.R.1919- Safeguarding America’s Pharmaceuticals Act of 2013) and the PI industry breathed a sigh of relief. Now, the FDA is back at it again.
PPLA which represents the manufacturers of patient inserts and a US senator ( Susan M. Collins) have written the FDA in protest of this proposed rule. They argue that shaky networks, power outages and rural locations will put patients and medical personal at risk. Furthermore, they argue that during natural disasters there may be no access to the internet. And, many communities around the country still have limited internet access. You can see that they have a point as power seems to be less consistent than it used to be. And, of course, every other day we are hearing about major computer system being hacked ie Sony Pictures being the latest creating huge issues for all involved.
Paper is bulletproof. It’s doesn’t need a computer or phone to be powered up to read it. It can’t be hacked. Paper is the best back up system that exists! Everybody can use it; All you need to do is be able to read.
Conversely, the FDA argues that professionals have wide access to the internet and that the patient information in paper form is wasteful and unnecessary.
Certainly, JH Bertrand is on the side of the PI manufacturers as paper backup is being proven over and over again to be a smart move for all involved. We hope the FDA will drop this proposal and follow what Congress debated and decided last year.
The location of the FDA document is http://federalregister.gov/a/2014-29522
On Monday, the Buffalo, NY metro area got hit with an intense lake effect snow storm that dumped 5 feet of snow (yes 5 feet not typo) in many areas south of the city. This created mass havoc in the southern area of the city with driving bans due to vehicles stuck everywhere. In the northern area of the city, virtually no snow fell.
We had many emails and calls from friends around the country asking how we were after listening to the “end of the world” media reports. They were very surprised to hear that we had only two inches on the ground. You can see in the second picture that there is a very clear line where the intense snow fall stops. This picture was taken about 1/8 of a mile from JH Bertrand which is why we didn’t have much snow. The first picture is an employee’s car in the driveway mile away. Ouch!
Football is a game of inches. Apparently, snow storms are as well. Aside from missing a few key employees, JH Bertrand is functioning normally today!
In the last 20 years, you couldn’t miss hearing or reading about somebody moving something from paper to electronic. It’s everywhere from coupons to online payments to newspapers to company brochures. Everything is going online. Nobody wants to use paper. It’s obsolete. It’s done. It’s not environmentally friendly. In fact, nobody wants to read something that isn’t on a computer screen or Smart phone right? Well, as with everything in life, what seemed to be a great idea is showing some glaring weaknesses.
Now (everyday) we are hearing and reading about huge network breaches. Home Depot, Walmart, Citibank, JP Morgan to name of few have had huge network break-ins opening up consumers and businesses to untold account fraud. JP Morgan’s breach affected 76 million customers alone. There are only 320 million people in the country!! Consumers and businesses are having to constantly change accounts or update passwords. Nothing seems secure anymore. There is a new saying that is going around the IT world: There are two kinds of people- those who know they have been hacked and those who don’t know they have been hacked. It’s a funny statement, but it is proving to be very true. The high point of this problem was marked by a story last year where the Russians decided to buy typewriters to shut down online leaks. Typewriters!!! LOL! How things come around.
The point here is that hard copy is a bullet-proof way to offer important information. Why put it on a shaky network where it is open to being hacked or where you need a device with power to read it? Hard copy is always there. It doesn’t take power to read it. It can’t be hacked. It will never go down. In a litigious world, hard copy offers peace of mind that the right information is getting to the customer keeping him/her safe while protecting the manufacturer from liability.
The next time somebody wants to put the product copy (eliminating the booklet label to save money the thinking goes) “in the cloud” and take it off the product package, think twice!
JH Bertrand is pleased to introduce its wholly owned subsidiary Bertrand Clinical Label. JH Bertrand has had a separate unit since 2001, but without branding it so. The company decided it was time for the unit to be recognized for its very unique functions. “The clinical industry demands such specialized processes and manufacturing which our clinical unit addresses very well. It only made sense to make it a separate distinct entity,” remarks Jeff Bertrand.
Aside from a new name, it also has a new dedicated website bertrandclinicallabel.com. BCL offers a very appealing value proposition …that booklet labels with random variable text should be less expensive that what is currently being offered in the marketplace which is detailed on the new website. “Clinical booklet labels with variable text are more expensive than average booklet labels because there is so much that goes into them to attain the proper quality, ” says Jeff. “But, we feel that the pricing in the industry could more sensitive to the cost pressure that healthcare is facing. BLC addresses that very issue while maintaining the proper level of quality.” BCL will offer a complete line of clinical products which includes single ply labels to booklet labels with peel off labels for application to case reports.
The company plans on adding additional variable printing equipment next year to its already robust capability.
We’ll be attending Label Expo in Chicago. If you want to meet up, please email Jeff Bertrand at email@example.com . Hope to see you there.
JH Bertrand is exhibiting at Contract Pharma again this year. Jeff Bertrand and Keith Schwertfeger will be there to represent the company. “Last year, the show resulted in a couple of large customers. Contract Pharma has always been a good show for us,” commented Jeff Bertrand. Please visit us at booth 116 on September 18th. The show hours are 10:00 am to 4:00 pm at the Hyatt Regency in New Brunswick, NJ. Come visit us!
We want to keep our customers and distributors up to date on what is trending in the marketplace with regards to booklet labels. We see growth in the following arears:
- GHS- Global Harmonization is a hot topic because the deadline is sometime in the middle of next year. We have a number of large clients who are very concerned with how they are going to handle the languages and symbols on small curved product.
Go to our note on GHS to find out more. http://www.jhbertrand.com/page/GHS/164.html
- e-Pedigree- This relates mostly to pharmaceuticals. Due to the wide spread counterfeiting of drugs, the FDA and pharma manfacturers want drugs to be serialized and coded to reduce this problem. JH Bertrand has the capabilities to add the appropriate codes for pharma booklet labels.
- Green Booklet Labels- Customers are asking about materials that can be used for recycling. They want their labels to have a more natural look. JH Bertrand can design a booklet label for you that addresses the look that you want to achieve.
- Where are the coupons labels? – Our channel checks show that far fewer coupons are being purchased this year. We are not exactly sure why, but customers seem to be trending toward smart phone coupon applications shown at the register rather than putting one on the product. For obvious reasons, we think that coupon labels are a very effective and won’t be replaced by smart phones etc. However, there is no denying that coupon labels are nowhere near as popular (for now) as they used to be.
- Multilingual booklet labels– business and products gets more global everyday. There is great cost savings in eliminating individual country labels in favor of consolidating all the information into booklet labels. Not only are we very skilled with languages, we offer technical translations services as well.
Coupon labels have been popular for decades. They are a great way to catch the attention of new customers and reward old customers. They are proven winners. However, we have recently noticed a sharp reduction in coupon label orders. We checked with other converters in the industry (at least 15 converters/customers) , and they report seeing the same thing. Everyone is saying coupon label business is slow. (This is only a small fraction of our business so it isn’t affecting us too much-thankfully) I was wondering why this might be the case. Frankly, I think there are some trends working against it. (1) The economy is still hurting in certain markets so people don’t want to discount their products. (2) More people are using Smartphone coupons where there is less cost for delivery. (3) More people are using the coupons that are given away at the register. (4) It’s the weather. LOL. I had to put that one in because everybody blames the weather for everything although you could make a case this winter.
If it’s the economy, this is interesting because the coupon business has traditionally increased during a poor economy so it just might be that companies are favoring other delivery methods right now.
I firmly believe that coupon labels will be around for a long time. You can’t beat putting something directly on the product. They really aren’t that expensive, and they are more obvious than something on a smartphone. But, with that said, it certainly appears that coupon labels are facing some stiff head winds right now. Not dead, but certainly a bit wounded for the moment.
The “cold vortex” is hitting our area today. It’s -2 right now with some white-outs, yet more than half our team is in. (Some couldn’t come because of driving bans in their area) I am proud to say that our hearty staff always does what it takes to keep things going for our customers! I am lucky to have such a dedicated group!! Jeff Bertrand
We get nice remarks like this all the time because we put heart and soul into making our customers happy. We truly have a passion for what we do. We wish everybody a Merry Christmas and Happy New Year!
(We removed the name for competitive reasons.)