Category Archives: Business

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.

14Jun/06

Are Post-it Notes Security's Worst Enemy?

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

14Jun/06

BearingPoint Joins SAFE’s Vendor Partner Program

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.

13Jun/06

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.