Archive for the ‘Pharmaceuticals’ Category

The Major Pharmaceuticals Losing Patent Protection in 2016

Posted on: December 16th, 2015 by Jeff Renoe 11 Comments

Click here to see our updated infographic on the pharmaceuticals losing patent protection in 2017.

2016 is going to be a big year. We’ll elect a new president, see our best athletes head to the summer Olympics in Rio de Janeiro and celebrate a leap year. However, 2016 is also a year to watch in the pharmaceutical industry. Several highly profitable drugs are going off-patent in 2016, losing the protection of the company that has held all rights to the drug – and ensuring that it won’t be long until cheaper generic alternatives hit the shelves.

The pharmaceuticals losing patent protection in 2016

 

What exactly does going off-patent mean? When a pharmaceutical company develops and “brands” a drug, it’s held under patent protection. Only the pharmaceutical company that holds the patent is allowed to manufacture, market and sell the drug. Patents in the United States usually run about 20 years, but patents are applied for well before the clinical trial begins, so the shelf life of a patent in the United States usually is about seven to 12 years.

What Happens When Patents Expire?

Manufacturers desiring to sell the now-generic version of a drug that has gone off-patent do not need to prove the safety and efficacy of the drug since that has already been done. Instead, they submit a New Drug Application (ANDA) to the Food and Drug Administration (FDA) intended to demonstrate that the proposed generic is the same as the previously approved drug. While it is commonly believed that the FDA’s drug approval process is slower than its foreign competitors, it is often faster and more willing to approve certain drugs. Seventy-five percent of the new drugs approved by both the FDA and European Medicines Agency (EMA) between 2006 and 2010 were first approved in the United States, while the FDA approved 32 of 35 prospective cancer drugs from 2003-2010. The EMA approved only 26.

What’s at Stake?

At Dickson, we’re all about data, and when it comes to intellectual property in the pharmaceutical industry, the numbers are staggering.

  • Estimates vary on how much it costs to bring a new drug to market, but a recent study from the Tufts Center for the Study of Drug Development (CSDD) pegs the average total at $2.9 billion. However, 95 percent of medicines fail during development, and only two in 10 recoup their research and development costs.
  • Once drugs lose patent protection, generics siphon off up to 90 percent of sales.
  • The average annual savings from switching to generic medications is estimated to be $420 per consumer.

Because of the high cost of research and development, pharmaceutical companies advocate for strong patent protection. The US is an outlier, however, with patent duration coming under scrutiny during the recent Trans Pacific Partnership (TPP) negotiations.

Who Stands to Lose Out?

AstraZeneca is one company in 2016 that is losing two major drugs from patent protection—Cestor and Seroquel XR—worth a combined annual revenue $7.34 billion. The top five biggest patent losses in 2016 per holder after AstraZeneca are Daiichi Sankyo, Merck, Abbott and ViiV.

Of course, there’s room here for consumers to gain. Four major HIV drugs also are going off-patent in 2016: Epzicom, Trizivir, Norvir and Kaletra, with a current cost-per-pill at $39.57, $11.07, $8.83 and $7.22, respectively. The good news? Costs for generics are 80 to 85% lower on average than those of patented drugs. It’ll make 2016 a big year for consumers who are in need of such medication.

The Do’s and Don’ts of Home Medication Storage

Posted on: September 6th, 2015 by Dickson No Comments

Medicine_Cabinet

When pharmaceuticals make it into our content, we have a tendency to write and discuss the manufacturing, engineering, and distributing side of the supply chain. What we rarely (if ever) discuss, is the link in the supply chain that most people interact with on a daily basis: the consumer and consumption side.

There are obvious reasons for this: most of our customer base is monitoring their drugs before they reach consumers. Dickson, for all intensive purposes is a B2B company, B2C is a smaller realm of our business.

That being said, it’s about time we talked about the consumer! Most, if not all of us have a medicine cabinet, herb cabinet, or first aid kit lying around our houses. Those things need to be monitored! Not monitoring with a temperature and/or humidity data logger per se, but kept safely stored and out of harm’s way. Here is our list of do’s and don’ts for home medication storage.

Do: Consult with your pharmacist.

Your pharmacist will know the intricacies of the drugs you are taking like the back of their hand. From storage conditions, to poison risks, consulting with the person who hands you your medication is worth the extra five minutes of your time.

Don’t : Leave expired drugs lying around.

Dispose of them correctly! Expired drugs are a disaster waiting to happen. Once you see the date on the bottle or container has been passed, stop using the drugs, and don’t just shove them back next to the tylenol. Annoying and a bit tedious, but a huge risk eliminator.

Do: Lock up your medication.

This one is a bit annoying as well, and may seem like overkill when it comes to vaccine storage. We swear, it’s not. For the protection of others around you, lock up your meds after every use.

Don’t: Store medication in direct sunlight.

Big time no-no. This is an inadvertent result of people not putting away and locking up (see above) their medication: it’s not like anyone tries to expose pills or liquids to direct sunlight. Rather, a large bathroom or kitchen window can lead to medication bottles and containers being hit directly by earth’s closest star’s light. That is never a good thing.

Do: Store room temperature medication in a cool, dry place.

We know temperature here at Dickson, and we know cool dry places. Basically, you don’t want to expose your room temperature medication to any extreme temperatures or humidity levels. Doing so can make the medication expire more quickly, or lose it’s potency.

Don’t: Ignore medication take-back programs.

We love these things! Just like you can recycle batteries safely, you can also recycle and dispose of medication safely. Leaving expired medication sitting around in your house is just asking for trouble. And throwing it out with the normal trash invites animals and humans to ingest it. So, research the medication take-back programs in your area for the drugs that you don’t use up.

Do: Know the phone number for your local poison control center.

9-1-1 should be your first choice when it comes to an emergency where too much medication was ingested by the wrong person, but having your poison control center’s phone number taped to the inside of your medicine cabinet is a great idea: they can give you relevant information that may prevent an emergency room visit.

Don’t: Forget about the elderly.

If you have a parent or grandparent suffers from memory lapses, alzheimer’s, dementia, or another brain-debilitating condition, this one should really hit home. When medication is one of the key aspects in fighting or stemming disease, forgetting to take medication, or taking the wrong amount, can be dangerous and devastating.

 


 

FDA Temperature Mapping and Monitoring Explained: A Dickson Translation

Posted on: May 18th, 2015 by Dickson No Comments
FDA Compliance Temperature Monitoring

FDA Compliance Temperature Monitoring

When it comes to regulatory bodies and concrete descriptions of how exactly you should be monitoring your environment . . . well it never comes to that.

Most regulatory bodies are vague in their recommendations for how you need to be monitoring your product’s temperature.

The FDA is no different.

However, there are some regulations out there that will help you avoid that dreaded FORM 483 from the FDA. In this edition of Dickson Translations we look to two FDA regulations and explain what they tell us about temperature monitoring in the food and pharmaceutical industries.

1. 21 CFR 110.80 – Food For Human Consumption

This section of the FDA’s Code of Federal Regulations speaks to the processes and controls associated with food for human consumption. It specifically states that ”Raw materials . . . shall be held at such temperature and relative humidity . . . to prevent the food from becoming adulterated…”

What it means: When storing the raw materials associated with food production, keep them at a safe temperature and humidity. Vague like most regulations, this FDA regulation does tell food producers something crucial: raw materials need to be monitored. This affects not only the manufacturer, but the supply chain that produces the raw materials for the manufacturer. It extends the reach of the FDA’s regulation of food.

2. 21 CFR 203.32 – Prescription Drug Marketing

This section of the FDA’s Code of Federal Regulations outlines the storage and handling requirements for drug samples. It states, ”Manufacturers, authorized distributors of record, and their representatives shall store and handle all drug samples under conditions that will maintain their stability, integrity, and effectiveness . . .”

What it means: All drug samples should be stored in proper conditions. It may sound strange to find a regulation on drug storage in a marketing regulation, but it sits there nonetheless. This regulation is important because it focuses on pieces of the supply chain that may normally go unnoticed. Drug samples are usually manufactured, stored, and shipped in much smaller quantities than entire batches of product. However, the FDA is stating that samples also must be stored under correct conditions. How do you prove you did that? With temperature monitoring.

 


 

 

Pharma Transport: Three Things You Need to Know

Posted on: May 12th, 2015 by Dickson No Comments

Transporting Pharmaceuticals Three Things To Know

1. YOUR TRANSPORT ROUTE IS BEING SCRUTINIZED

The World Health Organization (WHO) recently published guidelines for the storage and transport of time and temperature sensitive pharmaceutical products, and on the transport side, this was something that caught our eye. Qualifying the route your plane, truck, or ship takes is more than just saying,

“This is the most direct route.”

The WHO includes the following qualification parameters: weather data, laboratory tests, equipment tests, and field tests. Maybe most importantly, is the equipment qualification for the transport. If traveling through an especially extreme environment, auditors and regulatory bodies will want to know that your truck, and its cooling system were validated and qualified to hold up in such an environment.

2. THERE IS A TEMPERATURE TASK FORCE

The International Air Transport Association (IATA) is the global trade association for air transportation of goods, and represents over 200 countries. That organization is concerned with the quality of medical and pharmaceutical goods up in the air. So much so, they went ahead and created a task force to deal with temperature sensitive products.

That work group, the Time and Temperature Task Force (TTTF) will now begin creating guidelines for the pharmaceutical industry, and act as a liaison between the IATA and pharmaceutical manufacturers and distributors.

3. 10-MINUTE SAMPLE INTERVALS FOR TRUCKS

The WHO wants you taking and logging the temperature of your road vehicles at a specific interval, or at least no less than six times per hour per sensor position. That’s important, because many, many data loggers have a standard logging time of every 15 minutes. If you have data loggers in your truck, and are transporting pharmaceutical drugs, you need to have many of them, and they need to be taking the temperature of the inside of your truck at least every 10 minutes.


 

Why Process Validation Shouldn’t be Scary

Posted on: April 29th, 2015 by Dickson No Comments

If you’re in the quality assurance business like us, validation is a term you hear every day. “Validation” falls under the umbrella of terms businesses use to discuss the quality of their product, facility, or service. (Similar terms: IQ/ OQ/PQ, SOP’s, Storage, Deviation, Key Operating Procedure, and many more.)

For those not well-versed in the world of quality assurance, hearing ”validation” can send you running to hide under your desk. It’s a word that can scare you into a frightful Google search, an emergency call to someone in your quality department, or worse, it can scare you into ignoring it.

Why is that? We think it has to do with the widespread use of the word, without a concrete understanding. When a term like validation is used so frequently in the medical, pharmaceutical, and food industries, it can lose its foundation, and become a term that could mean anything!

And that’s scary to us. We’re in the validation industry. We build data loggers and temperature recorders used to validate HVAC systems, refrigerators, and even greenhouses. Having such an essential process like validation leaving our customers confused and disenchanted is bad for their product quality.

So we’d like to help. Here’s how we define validation:

“Documented testing done under controlled conditions and circumstances, to demonstrate the process, methodology, and specific systems used which will produce consistent results that meet acceptance criteria determined before the testing begins.”

That’s a lot of quality assurance jargon! We promise it’s really important jargon. If that definition leaves you confused, you can head over to our blog, Blog.DicksonData.Com, for a detailed breakdown of each term mentioned in the above definition. Just search “Validation.”