Category Archives: Regulatory


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.


FDA Task Force Report Recommends e-Pedigree in Distribution and Addresses RFID Issues

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:

  • Technical aspects of the mass serialization of marketed drugs by assigning a unique identifier or serial number to each drug package as the initial step in development of track and trace technology.
  • Importance of a nationwide universal drug pedigree with uniform information in preference to state laws imposing different pedigree requirements.
  • Protection of consumer privacy to prevent unauthorized disclosure of information stored in RFID tags when RFID-tagged drug products are dispensed to consumers.
  • Consumer education about RFID and the labeling of RFID-tagged drug products, to disclose to consumers when they are receiving RFID-tagged products and to inform consumers of the benefits of RFID technology and how consumers’ privacy is being protected.

The FDA has been busy providing guidance and direction on these important topics, now its time for the industry to move implementation into high gear.



FDA Issues Guidelines for Using Statistics in Device Trials Speak Now or Forever Hold your Peace

By Daniel R. Matlis 

Do you know that tense moment during the wedding ceremony, when the officiant says “speak now or forever hold your peace?” What happens if someone objects? Usually there are two outcomes, either the wedding is off or a brawl breaks out.

This is NOT one of those moments, and in this case, I would encourage you to speak your peace.

On May 23, 2006, 2 days after my son was born, The FDA released for comment a Draft Guidance for Industry and FDA Staff on the Use of Bayesian Statistics in Medical Device Clinical Trials.

This Guidance is part of the U.S. Food and Drug Administration (FDA) Medical Device Innovation Initiative. This initiative is aimed at making new medical devices available more quickly for patients.

“We must keep up with the rapid developments in science and technology to ensure that patients have access to the most advanced treatments available,” said FDA Acting Commissioner Andrew C. von Eschenbach, M.D. “By working with industry early in the evaluation process, we hope to foster development and speed up the approval of safe and effective innovative devices.” 

The Medical Device Innovation builds on the successes of MDUFMA and further modernizes the medical device review process in order to improve patient health and safety.

As part of this initiative, the Center for Devices and Radiological Health (CDRH) will expand current efforts to promote scientific innovation in product development, focus device research on cutting edge science, modernize the review of innovative devices, and facilitate a least burdensome approach to clinical trials.
In addition, this initiative includes:

  • Providing Regulatory Clarity Through Guidance Development
  • Investment in Critical Path
  • Conducting Stakeholder Outreach and Improve Communications
  • Laboratory Research to Support Efforts to Improve the Device Development Process
  • Implementation of a Quality Review Program
  • Leveraging Information Technology Solutions
  • Expanding Clinical and Scientific Expertise at FDA

The comments period expires 90 days from publication in the Federal Register announcing the availability of the draft guidance.

You can submit written comments (usually after checking with Legal and/or Compliance) to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.  You can also submit electronic comments All comments should be identified with docket number 2006D-0191.

So this is your chance, Speak Now or Forever Hold your Peace.

Well, maybe not forever, but at least until the next guidance document comes along.


Don’t forget the Process in PAT

By Daniel R. Matlis  

Do an internet search on Process Analytical Technology and you will be bombarded with sites for companies selling sensors, software and systems claiming to meet FDA’s PAT requirements.
I’m an engineer, and I like gadgets as much as the next person, but technology ought to enable change, not drive it.
Today I see companies following two distinct paths to PAT; one is technological, the other philosophical.

The technological approach to PAT, calls for the implementation of dedicated PAT systems.  This approach generally revolves around a specific technology or set of technology products and relies on a “silver bullet” to achieve the benefits of PAT. This is often driven by sensing or process analysis tools such as SPC, process modeling and process optimization.

This approach often involves the implementation of dedicated data acquisition tools and historians to gather and analyze the data in an information-only, non-validated environment.

The second and more holistic approach requires the development of a PAT philosophy and process across the enterprise. This approach sees technology as a tool to achieving process excellence as opposed to the end goal.

It is founded on mining the vast amounts of underutilized data currently available in automation manufacturing systems, such as SCADA, CIM, Historian, Batch, EBR and MES, It also looks to systems such as LIMS and ERP to correlate process and market data to identify key performance indicators and key process parameters based on historical information. This approach mines the vast amount of existing raw data and transforms it into actionable information through deep process understanding and data modeling.

To achieve the benefits of PAT, Life-Science companies need to design, analyze and control manufacturing through timely measurements of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality. 

Implementing technology before achieving process understanding is like putting the cart in front of the horse.


RFID on Prescription Drugs

By Daniel R. Matlis  

On the May 9th issue of Information Week, Mitch Wagner provides some simple and elegant solutions on his article entitled “A Simple Fix For RFID Privacy

In a previous article Levi Strauss proposal to use RFID tags on their Jeans was condemned by privacy advocates. He states “I’m not sure what the heck they’re worried about. I mean, how can you be concerned about privacy protection for information that’s already written on people’s butts?”

Although people may not be concerned about RFID tags in Levi’s Jeans, they ought to be concerned about RFID tags on prescription drugs.

The Food and drug administration (FDA) has issued a report recommending the widespread use of RFID technology throughout the pharmaceutical industry by 2007. The goal is to stem the tide of counterfeit drugs currently available though the internet.

RFID will play a key role in securing our nations drug supply. I can see a day were RFID tags will be the electronic equivalents of tamper proof seals, allowing consumers to rapidly identify counterfeit and fraudulent drugs.

However, there are significant privacy issues that must be addressed.

Would you want anyone with a rogue RFID reader finding out which prescription drugs you are taking?

I certainly would not.