**Johnson & Johnson Pharmaceutical Research & Development, L.L.C.\
920 ROUTE 202, P.O. BOX 300, RARITAN, NEW JERSEY 08869-0602**

Dockets Management Branch (HFA-305)

Food and Drug Administration

5630 Fishers Lane

Room 1061

Rockville, MD 20852

December 22, 2003

Docket No. 2003N-0361

Anti-Counterfeit Drug Initiative

Dear Sir/Madam:

The problem of counterfeit prescription drugs has been increasing in
recent years and poses a serious threat to the public health of
Americans. The best way to address this problem is for the private and
public sectors to join forces and develop systems and processes to
prevent counterfeiting, to identify counterfeit product that does enter
the supply chain and to prosecute and punish those who are involved in
this illegal activity.

Johnson & Johnson appreciates the opportunity to comment on the Food and
Drug Administration's Counterfeit Drug Task Force Interim Report. We
support FDA's goal of enhancing existing safeguards to protect the
nation's drug supply from counterfeit drugs. We agree with the
statements in the Interim Report that there is no single "magic bullet"
against the growing number of sophisticated counterfeiters, and that a
multi-pronged strategy is the most appropriate approach. We also agree
that new technologies hold the promise of ensuring the integrity of
these products in the future, when technologies are fully developed,
tested and implemented. Through the FDA's thoughtful and open dialogue
with the healthcare community on this and other important issues,
Americans can continue to depend upon one of the safest prescription
drug supply systems in the world. We support FDA's allocating sufficient
resources to the effort and look forward to working closely with the
agency and Congress in addressing these resource issues.

Johnson & Johnson is a comprehensive, broad based manufacturer of health
care products and related services for the consumer, pharmaceutical,
medical device and diagnostic markets. Johnson & Johnson has over 200
operating companies in 54 countries around the world, selling products
in more than 175 countries.

Unfortunately, like many other companies we have felt the impact of
counterfeit drugs; our product PROCRIT has been the target of
counterfeiters. Our comments are offered with the experience of having
had to deal directly with the threat to the health and safety of the
people who depend on the integrity of our products.

Although our company and others have taken important steps to combat
counterfeiting, it is clear that more work needs to be done on many
fronts, including improved control of the supply chain, stiffer
penalties for counterfeiters, improved technology for product packaging
and education for consumers, health care professionals and
wholesalers/distributors.

With these objectives in mind, we respectfully submit the following
comments that include our position on a number of important issues along
with details on some of the anti-counterfeiting measures we have taken.

[Distribution of Prescription Drugs]{.underline}

Johnson & Johnson believes that manufacturer-initiated policies to
secure the integrity of the supply chain, coupled with FDA-mandated
wholesaler and distributor certification requirements are the most
effective and immediate steps that can be taken to reduce the potential
for counterfeit product to enter the supply chain.

On December 10, 2003, our company issued a new policy to thwart
counterfeiters' attempts to access the supply chain. This new
anti-counterfeiting distribution policy requires direct purchasing
wholesalers and distributors to obtain prescription medicines and
devices directly from Johnson & Johnson companies (participating JOM
wholesalers and distributors). We are also encouraging pharmacies,
hospitals, and other customers to verify that their suppliers purchase
all Johnson & Johnson pharmaceutical, biopharmaceutical, and medical
device and diagnostic products direct from us, or participating JOM
wholesalers and distributors. This new policy is in addition to our work
to incorporate state-of-the-art anti-counterfeiting technology into
product packaging. Just last week, another major pharmaceutical company
adopted a policy similar to ours.

Close collaboration between all parties involved in the pharmaceutical
supply chain is critical to prevent the introduction of counterfeit
products into the market. Working together with our customers on this
new distribution initiative sends a strong message that we will not
tolerate activities that in any way compromise the health and well being
of the patients that we serve.

In order to further strengthen the security of the supply chain, we
recommend that the FDA certify wholesalers and distributors of
prescription products. Criteria to standards similar to cGMP standards
required of manufacturers the ability to immediately track and trace the
source and destination of products using lot numbers, and background
checks of employees who handle products.

[Track and Trace /Pedigree]{.underline}

Ensuring the authenticity of pharmaceutical products will require that
all parties involved in the U.S. prescription drug supply chain have
access to documentation related to the origin of products and definitive
verification that they arrived at the intended destination. Paper
pedigree documents have proven to be ineffective in that they are costly
to maintain and easier to counterfeit than the drugs themselves.

Johnson & Johnson agrees with the National Association of Chain Drug
Stores recommendation that until a broad based, electronic track and
trace system is implemented to ensure drug authenticity throughout the
supply chain, the "one step forward, one-step back" model (e.g. knowing
where a product came from and where it's going) should be adopted.

To ensure success, the FDA should work with all involved to define
required standards on key components and business practices of a
near-term, workable model. Further, the FDA should mandate industry-wide
implementation of this model.

-   A firm date should be set for industry adoption of the established
    model once a feasibility study has confirmed an agreed upon
    direction.

-   Develop and adopt a minimum standard for implementation across all
    sectors of the U.S. pharmaceutical supply chain.

[Increased Penalties for Counterfeiters]{.underline}

The current maximum penalty specified in the FD&C Act for counterfeiting
prescription drugs is three years in prison. This is not tough enough to
deter potential counterfeiters. Johnson & Johnson would support new
legislation to increase the penalties for this crime to be more
commensurate with the harm that these criminal acts can cause.

#### [Education and Public Awareness/Rapid Alert System]{.underline}

There needs to be increased education of both consumers and healthcare
professionals about how to detect counterfeit prescription medications.
This needs to be done in a way that empowers people but does not cause
undue alarm. A joint effort by the FDA and industry in this area would
show that there is a true public/private partnership to protect the
safety and health of all Americans taking prescription drugs.

Johnson & Johnson generally agrees with the proposal to use the MedWatch
Alert System to distribute information about counterfeit prescription
drugs. Although the system is not designed for this purpose, we believe
that with cooperation between industry and regulators that this could
prove to be a useful method of rapid alert.

[Packaging Technology]{.underline}

Like many pharmaceutical companies, Johnson & Johnson is implementing a
brand security program that includes the application of state-of-the-art
anti-counterfeiting technologies to the packaging of our major products.
We will continue to expand and modify these features over time.

We believe that the manufacturer is in the best position to select the
most appropriate and effective anti-counterfeiting technologies based on
the characteristics of the products, the costs of implementation, and
the risks of counterfeiting. We suggest that FDA allow individual
manufacturers to select the appropriate technologies for their products
since they have the expertise in product development, manufacturing, and
package design.

Medications considered by manufacturers and the FDA to be at "high risk"
for counterfeiting should be the first to implement anti-counterfeiting
technology. Further, we recommend that all newly launched products
should include anti-counterfeiting features, and that all NDAs, BLA's
and ANDAs include an assessment of the likelihood of counterfeiting, and
the type of actions the firm will take to prevent it. This could be
similar to the environmental assessment that is currently part of these
submissions.

While radio frequency identification (RFID) has received much attention
over the last several months in terms of a potential solution to the
issue of counterfeit pharmaceuticals -- and as a mechanism to gain
better control of the distribution system -- it should be noted that the
uniform implementation of this technology is a long-term commitment.
Interim steps using known technologies must be taken by all involved in
the pharmaceutical supply chain to address the counterfeit issue.

[Unit of Use Packaging]{.underline}

While the FDA has identified unit of use packaging as a potential
anti-counterfeiting solution, Johnson & Johnson believes that the
downsides, especially the ability of counterfeiters to duplicate unit of
use dosing, outweigh the benefits.

The sophistication of counterfeiters is significant. Although the
equipment required to duplicate unit of use dosing is costly, we believe
it would just be a matter of time before this type of packaging becomes
the target of counterfeiters.

Also, many prescription drug therapies do not easily lend themselves to
unit-of-use packaging and standardized dispensing quantities. A number
of medications require dosing based on specific details of a patient's
condition. At the retail level, unit of use dosing would require
significantly more space on pharmacy shelves for the same medication,
and this could result in fewer products carried in pharmacies, an
inconvenience for consumers. For pharmaceutical manufacturers, the
significant retooling necessary to broadly institute unit-of-use
packaging would be costly. From an environmental standpoint, far more
material is required to package the same amount of medication, resulting
in significantly more waste.

[Repackaging for Resale]{.underline}

Johnson & Johnson believes that repackaging of prescription medications
should meet all of the cGMP requirements of the originating
manufacturer.

During repackaging, the manufacturer's original packaging is broken down
to pill and vial levels destroying the original package integrity. This
creates an opportunity for the entry of diverted and counterfeit drugs.
In addition, the repackager may not have the appropriate controls based
on the manufacture's approved process, product and packaging
specifications. Once track and trace technology is adopted, repackaging
should be required to apply lot numbers that enable the supply chain to
track and trace lots from either end of the chain.

[Conclusion]{.underline}

Johnson & Johnson is committed to working with the FDA, other government
agencies and our colleagues in industry to protect the American public
from the scourge of counterfeit drugs. It is the responsibility of all
parties involved in the manufacture, distribution and sale of
prescription drugs to take part in this effort.

Sincerely,

Patricia DeSantis

Senior Director, Regulatory Affairs

Johnson & Johnson PRD