Department of Justice

Drug Enforcement Administration April 16, 2008

Dear DEA and staff,

I am writing in response to the proposed rule published in the [Federal
Register]{.underline} on March 31, 2008, to require all information
regarding the foreign chain of ephedrine, pseudoephedrine, and
phenylpropanolamine distribution to be in the import declaration. I have
prepared the following comments for your consideration.

I am a healthcare provider who is responsible for the safety and
wellbeing of the patient population that I serve. I have been practicing
the science of medicine and have been managing, diagnosing, and treating
patients for ten years. When faced with the many decisions and
complexities regarding patient care and prescriptions, it is most
concerning for me to think about the dangers of medication
contamination. Both the healthcare provider and the patient are becoming
more and more aware of just what those dangers entail. The current
regulation regarding pseudoephedrine is important to me.

[Rule:]{.underline}

I support the DEA addition to 21 CRF 1313.13 to state that importers of
ephedrine, pseudoephedrine, and phenylpropanolamine must provide
information known to them on the chain of distribution from the
manufacturer to the importer. I also support 21 CFR 1313.42 on orders to
prohibit imports from foreign manufacturers and distributors who refuse
to cooperate with requests for information. I support this rule because
I have found that improving drug safety can save lives. The following is
an explanation of why I support the FDA's effort for improved security
of this medication.

The proposed DEA regulation would work to strengthen US medication
security. *However, I am concerned with regard to the implementation of
this rule. Both my support and my concern are included in the
explanation below.*

[Risks to the consumer:]{.underline}

The enactment of the combat methamphetamine Epidemic Act in 2006 has
already been shown to improve this drug problem in the United States.
Studies have found that the number of U.S. employees who tested positive
for meth decreased 22 percent overall in 2007. In addition, the number
of illegal meth labs has decreased from 7,347 in 2006 to 5,080 in 2007.
This is a decrease of 31 percent. Cocaine use in the workforce decreased
by 19 percent last year.^1^ *This proposed regulation has the potential
to change more than just the methamphetamine problem in the US. It has
the potential to begin to improve the safety of medication distribution
and the potential to save lives by ensuring strict importation
regulation.*

Currently, the FDA lacks the authority to require information on all of
the manufacturers, distributors, or transporters that have a role in the
manufacture of a drug from a foreign country.^2^ New consumer safety
risks have surfaced due to globalization in drug manufacturing and
ingredient sourcing. The FDA is inspecting every licensed drug plant in
the United States to check for federal regulation compliance. However,
the FDA lacks the clout and resources to inspect drug manufacturing
abroad. It is relying on volunteer evaluators to track products that are
exported to the United States. Inspection teams send inspectors to
*only* an estimated 7% of known plants. Experts state that China and
India produce nearly 40 percent of the active ingredients in drugs
consumed in the US. Many of these ingredients are in the generic version
of the drug.^2^

The healthcare provider is required to make a decision in many states to
choose whether to dispense a name brand, verses a generic brand to their
patient. How is the clinician supposed to make an informed decision of
how to do this in a practice setting in the face of this information?
The clinician must decide if the potential risk of using a generic
prescription outweighs the cost burden of the medication to the patient.

This safety problem is also evidence by the recent events involving
Baxter International Inc. in China who distributed tainted Heparin with
chondroitin sulfate. At least 19 patients died and hundreds of other
patients became severely ill.^3^ Additionally, in the late 1990's it was
found that a spike in deaths associated with the IV antibiotic
gentamicin was linked to a China-based Long March Pharmaceuticals.^4^

[Rule Implementation:]{.underline}

With regard to the regulatory certification: Regulatory Flexibility Act,
I am concerned with the following which can be found under regulatory
certifications for the proposed rule, "DEA notes that the statute
requires importers to provide only information that is known to them;
the burden associated with providing names on the foreign chain of
distribution will be minimal". I am also concerned with the following,
"Therefore, this rule will not have a significant economic impact on a
substantial number of small entities". I support, that in fact, the
burden of finding out the distribution of foreign chain *is* to be the
responsibility of the importer. A drug that comes into the US goes
through a series of processes. It goes from the raw material, to foreign
manufacturers, to distribution, to foreign shippers, to the customs
broker at the port of entry, and finally to the importer.^2^ It is time
to ensure product quality and safety of overseas medications. *It is in
the interest of the importer and all parties concerned to be able to
report to the DEA where the medication is coming from.* This will help
to ensure that the drug is coming from a facility that is trustworthy.
This would be a small price to pay for saving and protecting the lives
of our citizens.

The United States can become innovative and seek solutions that will
provide effective, safe, and economical pharmaceuticals. Portable
instrumental methods of analysis and electronic tracking are examples of
modern tools applicable to identifying articles in transit and their
distribution. In addition, radiofrequency identification could also be
used to ensure safety.^1^ *The DEA, through this regulation of safer
medications, can begin to solve this problem of medication safety
burdens of the North American citizen.*

[Conclusion:]{.underline}

In conclusion, I urge that the DEA consider the position that this rule
has the potential to do more. It has the potential to improve the safety
of the industry even further by putting the burden of finding the
foreign chain of distribution on the importer. This will begin to ensure
further drug importation safety. Thank you for your consideration.

Bibliography

1.  Washington Post (2008). Health Highlights: Retrieved 3/23/3008
    <http://www.washingtonpost.com/wp-dyn/content/article/2008/03/12/AR2008031202057.html>

2.  Woo J. Wolfgang, S. The effect of globalization of drug
    manufacturing, production, and sourcing and challenges for American
    drug safety. \[Journal Article\] *Clinical Pharmacology and
    Therapeutics*, 83(3): 494-497, 2008

3.  Armstrong D. A hard look at the FDA. \[Journal Article\]
    *Congressional quarterly's magazine on government, commerce and
    politics*, 868-876, April 2008.

4.  Washington Post (2008). Contaminant in Heparin is identified.
    Retrieved 3/13/2008
    <http://www.washingtonpost.com/wp-dyn/content/article/2008/03/19/AR2008031901548.html>