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!
The trend we see everyday in the labeling and packaging business is the desire to pair down the supplier base- sometimes to a single source of supply. The main argument is that is saves money by giving the buyer a bigger spend (more leverage) with fewer suppliers. It is also believed to make the supply chain easier to manage. Fewer moving parts as the theory goes.
But (and it is a big but), there is a significant downside. With fewer suppliers, there is risk that a “problem” could end up being a catastrophe for the buyer. One of the best examples of this is Lululemon and their single source of the Luon fabric. The company had a quality problem with their fabric from their single source supplier that forced them to do a major recall of their very popular yoga pants. You may recall that the pants were too thin making it embarrassing for many who were practicing yoga with the Lululemon pants on. The company was forced to do a major recall, but had no other supplier to turn to while the supplier with the problem tried to solve the problem. In the end, they lost their long time CEO Christine Day who had grown the business 5x since she started. They lost 2 billion dollars of market cap on the day Ms. Day resigned. The end result was a lost CEO, 2 billion dollars of market cap reduction and a blistering in social media that destroyed the image the company spent years earning. All this came from a very lean supply chain!
We’ve seen the same thing in the label business. A number of booklet label buyers in chemical and pharma have elected to go to single source. The result isn’t quite as dramatic as Lululemon, but we have heard that those companies are getting inconsistent service which means missed deliveries and slower response times. If their single source plant is too busy…well….they just have to wait until there is press time. That’s no good in today’s fast paced distribution networks. It could also mean something much larger if something happens to the plant like a sale, a fire, a natural disaster, bankruptcy, management change etc.
Smart companies realize that single source is a disaster waiting to happen. In fact, there is a counter trend now toward risk mitigation which is questioning the practice of trying to skinny down the source of supply to a point where a “hiccup” could cripple the company. Buyers should think twice about making their supply chain too lean or they risk severely damaging their companies.
If you want to know more about the Lululemon story, there is an excellent write up written by the Stanford Closer Look Series. It’s called Lululemon: A sheer Debacle in Risk Management.
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.
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!
Once in a while, you have a chance to live a special moment. On Father’s Day, I had the opportunity to fly with my son Jack in a helicopter piloted by a good friend of mine- Jake. What an experience!
When we got to the hanger, we had to check the helicopter carefully including adding some oil. Once the check was over, my son pushed the bird out to our takeoff area. It took a few cranks to start it up and then we were off. A couple on bicycles stood at the end of the runway watching until we left. Everybody seems to love helicopters.
We flew 300 feet off the ground our entire flight seeing amazing sites from a different perspective- green ow pastures, beautiful homes, lakes, small towns and waving people. Our hour long flight started in Hamburg, NY and stretched out to Rushford Lake (seen above). Often, we used the GPS on my Droid phone as our navigation instrumentation which is crazy when you think about how commercial jets are flown. A few times, we followed roads to find our way.
Jake gave my son and me a special Father’s Day gift. The excitement stayed with us for days after. I am so thankful to have those special moments with my kids.
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.
In an ultra competitive world, companies need to be more creative about how they attractive new business. Asking lots of questions and being a consultant is one of the top ways to be more to your customer. By asking good questions, you can find “pain” that needs to be addressed. For example, a customer may find that it is costly to inventory 24 individual country languages for a medical product that is shipped to multiple countries. Your suggestion would be to consider a multi paged booklet label that turns 24 pages into one inventory item.
We take this process one step further. We review the business and look for issues that the customer may not know they have. The buyer probably knew that her inventory issue with the different country labels was a problem. She simply didn’t know the best way to solve it. The former is good, but your “A game” is to bring up issues that the customer is unaware that she is going to have.
A good example might be telling a customer about GHS in the early days of development. Global Harmonization is a global project that involves getting chemical companies to use the same symbology on their products across all countries involved. This makes it safer for the users and less confusing for the chemical companies when they prepare their labeling. You would stand out by bringing the issue up with the company as most sales people are more interested in addressing what is known rather than doing research and presenting what is unknown. It is much easier to become a supplier to a company when you come with fresh ideas on how to help with future problems. This gives the buyer a chance to address the future issues early with her company. Taking out any political issues, this can do nothing but make everybody look good.
If you want to be valuable to your customer/partner, you must take the consultative sale to the next level. The business, the buyer and you will all gain.