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By Daniel R. Matlis 

It’s 3:00 AM and your newborn baby wakes up crying. You want to go back to sleep, but his circadian rhythm is set for Beijing, not Philadelphia, and he is wide awake.So you get a cup of coffee, turn on your laptop and start to do some work. In a moment of inspiration, you discover the cure for the common cold. It’s all there on the screen right in front of your eyes and then your baby kicks, the coffee spills on your laptop and, just like that, the cure is gone. Who do you call?

By Daniel R. Matlis

Johnson & Johnson already had the title of the world’s most comprehensive and broadly based manufacturer of health care products, but with today’s announcement, it also becomes the World’s Premier Consumer Health Care Company.

With the levels of disposable income in developing nations increasing, and the profit margins for prescription drugs and decreasing, the acquisition provides a strong diversified footing for J&J in the healthcare arena. As consumers take greater interest and responsibility for their own health, OTC products are an attractive compliment to Johnson and Johnson’s Pharmaceutical and Medical Device sectors. 

This acquisition continues J&J’s long standing practice of broad diversification in the Life-Sciences and Healthcare markets.  “Being broadly based in health care allows us to leverage our expertise in science and technology across our businesses,” Weldon said. “Through this acquisition, we look to benefit both from Pfizer Consumer Healthcare’s excellent product portfolio and pipeline and from the valuable skills and experience of its employees.”

As our world continues to flatten, it is key to look at emerging markets as consumers not just producers.

This is a fine strategic move by Johnson & Johnson.

By Daniel R. Matlis

According to the Food, Drug, and Cosmetic Act, FDA statutorily required to inspect domestic drug manufacturing establishments at least once every 2 years.

There is just one problem,  the number or  registered human drug establishments has increased in the last 25 years while the number of FDA human drug inspections has decreased over the same period.   To address this issue, the FDA has implemented the “Risk-Based Method for Prioritizing CGMP Inspections of Pharmaceutical Manufacturing Sites”. This model, commonly known as the Site Selection Model, utilizes a risk-based inspection approach for prioritizing drug manufacturing establishments for routine cGMP inspection. The model is based on a risk-ranking and filtering method that is well-recognized, objective, and rigorously systematic. Currently there are 3 empirical factors used to calculate a site’s selection score. 

They are:

1. Product Risk: Factors such as sterility, medical gas, and the determination of prescription (Rx) versus over the counter (OTC) currently in the model are crude surrogates to distinguish between products with higher and lower potential for public health consequence should there be a drug defect.
2. Process Risk: Some processes are more complex and more susceptible to problems than other processes. The key issues in the implementation of the risk-ranking model involves questions concerning the relevant inherent process risk factors, the relevant process control and risk mitigation factors, and how to weigh/rank them
3. Facility Risk: Currently, the facility component of the risk ranking model includes 4 factors:

• History of violation (e.g., CGMP deficiencies have higher weights)
• History of inspection (e.g., no prior inspection, newly registered/licensed or no CGMP inspection in the past 2 years have higher weights than those with recent CGMP inspection)
• Estimated volume of production output (surrogate for exposure, e.g., higher volume and production output, higher weights)
• Type of establishment (e.g., manufacturer, repacker, contract lab)
   

According to Joseph Famulare, acting Director of CDER’s office of compliance, in addition to these three empirical factors, “expert elicitation with emphasis on current FDA priorities is used to determine site selection”. “For example, last year trans-dermal patches were a priority at the agency” said Famulare, so the number of inspection in that area increased.

Famulare said “just under 50% of the cGMP inspections last year were based on the Site Selection Model, with the remainder done at the districts discretion.”

Next year, a new category will be factored in the empirical portion of the calculation. Recall data has already been entered in the database and will be used for Site Selection Model.

You heard about your credit score, it’s time to keep and eye on your Site Selection Score.

By Daniel R. Matlis

In the past few years, CDER has made significant changes to advance and facilitate the review of electronic regulatory submissions. These include spearheading projects to standardize information management processes, publish regulations and guidance documents to support electronic submissions, and facilitate the development of information management project proposals, which will benefit the consumer and the pharmaceutical industry.

As evidence of the positive impact of these changes, over 3000 e-CTDs have been submitted to the FDA since the it began accepting them 2 1/2 years ago.

Many of these improvements are the work of the Office of Business Process Support (OBPS) at CDER.   “Through the use of the Project Development Staff and other resources within OBPS we started to develop more specialized experience so that over time we are able to turn around this projects more quickly and with higher quality” said Gary M. Gensinger Director of Regulatory Review Support Staff, OBPS at CDER. He continued “that’s what it’s all about.”

Another key area addressed by OBPS is standards. “It’s not about doing the same thing for the sake of doing the same thing, but trying to find out what’s the best practice” said Gensinger. To my surprise and delight he went on to say ”it’s about finding what is the most efficient and most effective way to move forward, so that what limited resources we do have, we can spend that in the review process”.

The FDA is making a concerted effort to harmonize internally as well as externally to focus as many resources as possible on the “Receive, Review, Report” process.

With all this talk about doing more with limited resources, and looking for the most efficient and effective ways get things done, can regulatory outsourcing offshore be the next step?

 I certainly hope not. Regulatory Oversight is not a function we want to outsource.

By Daniel R. Matlis

“This is a Challenging time for the FDA and the Industry” said Janet Woodcock, MD, FDA’s Deputy Commissioner of Operations and Chief Operating Officer, at the Drug Information Association’s 42nd Annual Meeting.

She listed 6 key trends facing the industry:

1-Biomedical Science Investment by industry is beginning to pay off with new personalized medical treatments and combination therapies.

2-Healthcare is entering the Information Age in the US where patients are not waiting for Doctors to assess their condition. With access to information on the internet, patients are going to the doctor’s office armed with information on their condition and possible treatments options.

3-The shift in population trends and level of activities have caused obesity and nutritionally related illnesses to reach an alarming level.

4-The cost of healthcare has had a severe impact on industry competitiveness. Healthcare economics, not outcomes are directing patient care.

5-Globalization is requiring the FDA to look outside of its originally mandated domestic jurisdiction.

6-Constraints on FDA resources are challenging the agency in the face of higher expectations from Congress and the American public.

To respond to these realities, the FDA must undergo a transformation. The agency must become an “enterprise agency instead of separate centers” said Woodcock alluding to the silos within the agency.  “The public wants to interact with one FDA, not separate centers” she added. 

As we move away from therapeutic areas and into solutions based medicine, including pharmacogenomics, personalized medicine and combination products, “FDA must become an information provider as well as a regulator” said Woodcock. Her mandate is to re-assess the agency’s structure to leverage technology investment and human capital across the agency.

By Daniel R. Matlis

The American Medical Association’s new policy on Direct to Consumer Advertising includes imposing a temporary moratorium on newly approved drugs and guidelines for pharmaceutical companies to follow when preparing DTC advertising.

AMA President-elect Ronald M. Davis, MD said “A temporary moratorium on DTC advertising of prescribed drugs and medical devices will benefit both the patient and physician.” He added “Physicians will have the opportunity to become better educated on the pros and cons of prescription drug uses before prescribing them, and will be better able to determine when they are best suited for their patients’ medical needs.”

The AMA suggested the following guidelines for DTC ads:

• provide objective information about drug benefits that reflect drug efficacy, as determined by clinical trials
• show fair balance between the benefits and risks of the advertised drugs by providing comparable time or space and cognitive accessibility, and by presenting warnings, precautions and potential adverse reactions in a clear and understandable way without distraction of content
• clearly indicate that the ad is for a prescription drug and refer patients to their physician for more information and appropriate treatment
• target age-appropriate audiences
• should receive pre-approval from the FDA

“The AMA will work with the pharmaceutical industry for universal acceptance of the guidelines so that physicians can help patients obtain appropriate medications” said Dr. Davis.

Let’s see how the FDA and PhRMA respond.

By Daniel R. Matlis

In his recent InformationWeek article entitled “Let The UBS Trial Be A Warning To You” Mitch Wagner covers the trial against a former UBS employee charged with hacking the company’s networks. The article also addresses some of the embarrassing failures in UBS’s security and disaster preparedness.

According to testimony from a UBS IT manager, some 40 systems administrators at the company shared the same ‘root’ password to login. There they had free rein to install software or make any changes they wished. It was not unusual for systems administrators to get up from their desks and wander off while still logged in as ‘root’.

It is a fact that companies often spend millions implementing the latest and greatest security technology. The rationale is that technology will keep us secure.

The reality is that the best security technology is not worth a dime if people find a way around it. People must me trained and reminded of proper security procedure. For example don’t share passwords, it’s like giving your ATM card and PIN to anyone who asks, delete default passwords, remember Oracle’s Scott/Tiger and most everyone else’s Admin/Admin.

But in my experience, Post-it® notes are security’s worst enemy.  I cannot tell you how many times I walk up to someone’s desk and stuck to the monitor is a Post-it® notes with a list of system names and their respective passwords.

The path to security begins with people. Let’s not confiscate all Post-it® notes in the company. Instead, let’s train our people on proper security procedures.

Post-it® is a trademark of 3M

By Daniel R. Matlis

BearingPoint announced today that it will provide services to help pharmaceutical and healthcare organizations implement SAFE (“Signatures and Authentication For Everyone”)

SAFE is a network of recognized trusted healthcare professionals and an identity management standard and associated operating rules that deliver unique identity keys for regulatory compliant and legally enforceable digital signatures.

SAFE is designed for the purpose of simplifying, securing, and streamlining business-to-business and business-to-regulator information exchange. The SAFE standard consists of policies, procedures, guidelines, technical specifications and a legal and liability risk management framework for ensuring the validity of the electronic signatures used for information exchange and electronic submissions to regulators.

The SAFE standard promotes interoperability and integration among researchers, vendors, regulators, clinicians and other pharmaceutical and healthcare stakeholders.  It provides a secure, enforceable, and regulatory compliant way to verify the identities of parties involved in business-to-business and business-to-regulator electronic transactions.

As one of the world’s largest management and technology consulting firms, BearingPoint will add significant momentum to the SAFE initiative. After all, if there is one thing big consulting firms can do it’s to sell technology.

by Daniel R. Matlis

In a long awaited move, the FDA announced on Friday June 9th, that it will fully implement regulations related to the Prescription Drug Marketing Act of 1987, which requires drug distributors to provide documentation of the chain of custody of drug products — “pedigree” — throughout the distribution system.

Consistent with recommendations from the FDA Counterfeit Drug Task Force, the agency also announced that its enforcement of the pedigree regulations will focus on products most susceptible to counterfeiting and diversion.

FDA also announced the availability of a Draft Compliance Policy Guide for public comment describing this enforcement approach. By providing guidance on the types of drugs that are currently of greatest concern to FDA, the agency intends to give wholesale distributors a better idea on where and how to focus their initial energies to come into complete compliance with the regulations (21 CFR Part 203) for all the prescription drugs they distribute.

Additional subjects discussed in the Task Force’s report include the following key issues related to electronic track-and-trace that are in need of resolution:
 

By Daniel R. Matlis 

The Life-Sciences industry is undergoing a metamorphosis. Historically separate disciplines, like pharmaceuticals, devices, diagnostics, biotech, and even nanotech, are converging.

This trend will accelerate as personalized medicine and genetic therapies evolve. In the not to distant future, your Doctor will be able to target specific medical treatments to address your condition based on your unique DNA.

This shift to convergence medicine is already underway with the combination of traditional pharmaceuticals and medical devices.  Products like drug coated stents and antibacterial sutures are breaking down the traditional barriers in healthcare.

Today, pharmaceutical companies are looking to biotech firms for innovation and new ways to treat conditions.

Read more about this trend and my opinion on it in Chemicals to Cell Culture published in this month’s issue of Intech Magazine.