26Jun/06

Johnson & Johnson to Acquire Pfizer Consumer Healthcare

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.

23Jun/06

What’s your FDA Site Selection Score?

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.

22Jun/06

Efficiency, Effectiveness and FDA All In The Same Sentence?

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.

21Jun/06

FDA Must Become An Information Provider As Well As A Regulator

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.

16Jun/06

AMA Calls For Moratorium On Advertising Of Prescription Drugs And Devices

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.