AN OFFICIAL PUBLICATION OF THE AMERICAN SOCIETY FOR PHARMACY LAW

Volume 37 Number 4

July/August 2010

In the March/April issue of Rx Ipsa Loquitur, I brieflydiscussed how the Board appointed a Technology andWebsite Ad-hoc committee to work with our ExecutiveDirector on revamping our website. The committee hasmet on several occasions, researched potential companiesto work with, and made a recommendation to the Boardas to what company to collaborate with to improve ourwebsite. The Board has approved the committee’srecommendation, and has decided to contract withMemberClicks. Over 1,400 associations engage withMemberClicks to enhance their web presence and tosimplify membership management. MemberClicks offersservices that will improve ASPL, including membershipdatabases, interactive web pages, and online registration.

As the committee starts their work withMemberClicks, the Board will look to members to providesuggestions and feedback on potential content for ournew website. Please watch for future surveys, or feel freeto contact any Board member with suggestion regardingour website development. We will continue to keepmembers informed of the website development, and welook forward to unveiling a new ASPL website in the nearfuture.

ASPL’s Fall Seminar is coming up in November in LaQuinta, California. Information about the educationalsessions is included in the newsletter. I’m sure theeducational sessions will be great as always, and I personallylook forward to seeing many colleagues at theconference. You can register for the Seminar online atwww.aspl.org. Please note that when you make yourroom reservations, inform the resort that you are attendingthe ASPL/NASPA conference.

I would again like to thank everyone for their supportof ASPL – from the hard work and commitment of theBoard of Directors, ASPL committees, our ExecutiveDirector, and of course, all our members!

President’sMessage

Kimberly BurnsASPL President

Probiotics ChallengeExisting Regulatory Structures

By Francis B. Palumbo, PhD, JD

Probiotics are coming into increasing use in the U.S. Perhaps the most wellknown is Dannon’s Activia®, a yogurt product which claims that “Including Activia®in your daily diet can help regulate your digestive system by helping reduce longintestinal transit time.”1 There are many other types of probiotic products in themarketplace at this time and these include probiotic dietary supplements, probioticcosmetics, probiotic vaginal products, probiotic dental products, probiotic devicesand others.

Probiotics are defined as live microorganisms that when administered in adequateamounts confer a health benefit on the host. This is a rather broad definition andcovers a great deal of regulatory territory. It is important to note that probiotics do notconstitute any particular regulatory class within the Food Drug and Cosmetic Act (theAct) but cut across many established categories. It is also important to note that whilesome probiotics are often described as functional foods, there is no “functional food”definition in the law. What the Act does include are some longstanding definitions aswell as some more recent definitions that basically dictate the claims that can be madefor any product.2

Many of the product categories in the Act have a well developed history of lawand regulations allowing certain statements. These include certain allowable claims onfood labels. For example, a statement such as “use of calcium in the diet on a regularbasis may help to reduce the risk of osteoporosis” must be approved by FDA and mustbe based on significant scientific agreement among experts.3 This standard is certainlyless stringent than a randomized controlled trial that would be expected for anInvestigational New Drug (IND) study. If the label is characterizing the level of anutrient, such as Vitamin C, FDA must have issued a regulation authorizing such or itmust be based on an authoritative statement by a scientific body. Certain structure-function claims are allowed for dietary supplements and foods and they must be“truthful and not misleading,” reflecting more an FTC style approach. Examples ofthese claims might include such statements as: “helps support a healthy immunesystem,” or a claim that describes the relationship between calcium and strong bones.Yet since this area of probiotics has become so broad, there are many instances where itmay be difficult to discern whether a claim meets the requirements of the particularproduct category where it seemingly fits, or whether it crosses the line into becominga drug.

As one can imagine, FDA is extremely concerned about claims that would rendera product a drug. For if this were to occur the product would now be an unapprovednew drug and would require that the manufacturer obtain an IND, conduct clinicaltrials and spend enormous amounts of money to obtain drug approval. But thathaving been said, these manufacturers are really not interested in making drugs as

Continued on page 5

American Society for Pharmacy Law2

Does the California Drug Dealer Liability ActApply to a Pharmacy Whose Employee Steals Drugs

and Sells them to Addicts?Whittemore v. Owens Healthcare-Retail Pharmacy, Inc.

CO60873 (Cal.App. 06-22-2010)By Sara Millar, JD and Roger Morris, BS Pharm, JD

In June, the Court of Appeals of California, Third District rejected a plaintiff ’s claim that apharmacy was liable under the Drug Dealer Liability Act for the conduct of an employee whofurnished stolen prescription pills to the plaintiff.

The plaintiff, Melody Whittemore, was treated by a doctor for a severe infection, but wasunable to pay for the medication the doctor had prescribed. After receiving a tip from a friend,she began receiving pain medication from Steven Correa, an employee of the defendant, OwensHealthcare-Retail Pharmacy, Inc. Over the span of a year and a half, Melody paid Correa over$330,000 in cash for the pain pills. Eventually her husband discovered her addiction and shewas hospitalized. Melody later cooperated with drug enforcement officers to expose and arrestCorrea.

Sometime thereafter, Melody and her husband, Kennith, learned that pharmacies are requiredby law to monitor medications in their possession and to report missing medication to the DrugEnforcement Agency. Melody alleged that the pharmacy failed to do so, thereby being instrumentalin Melody receiving the painkillers from Correa and acting in reckless disregard for Melody’swelfare. Melody’s husband, Kennith, also sought damages for severe emotional distress based onseveral different legal theories. The trial court sustained the pharmacy’s demurrer without leaveto amend on the ground that the plaintiff could not recover for her injuries caused by her ownillegal conduct. Kennith’s claims could not survive without Melody’s.

Melody and Kennith argued that the trial court erred in ruling that the doctrine of uncleanhands barred her claims, but the appeals court disagreed and upheld the trial court’s decision.The court explained that the unclean hands doctrine was created to protect judicial integrity andto promote justice because “allowing a plaintiff with unclean hands to recover in an action createsdoubts as to the justice provided by the judicial system.” Conduct that renders a plaintiff ’s hands“unclean” does not need to include a crime or actionable tort, but could be any conduct thatviolates conscience or good faith. The court found Melody’s conduct in this case to be particularlyegregious given that she illegally acquired, possessed, and used controlled substances not justonce, but repeatedly over a period of 18 months. Therefore, the court would not allow Melodyto recover when her “unclean” hands contributed to her injury.

Melody and Kennith also argued that an exception should be applied to the unclean handsdoctrine due to the existence of the Drug Dealer Liability Act (Health & Safety Code §§ 11700et seq.). The purpose of the Act, the court explained, was to allow persons who were injured asa consequence of the use of “illegal controlled substance” to recover damages from those whoparticipated in the marketing of the substance in order to shift the cost to those who illegallyprofit from that market. (§§ 11701, 11702). The court further explained that the Act had ascienter requirement for liability and that only those who “knowingly participates in the marketing”of such substances could be held liable. (§ 11704(a).) The pharmacy did not “knowinglyparticipate” in the marketing of the controlled substance to Melody, therefore it could not beheld liable for her or her husband’s injuries under the Act.

Sara Millar is an attorney with Quarles & Brady’s Health Law group in Madison, WI; Roger Morrisis chair of Quarles & Brady’s Health Law group.

Featured Case

AccommodationsA block of rooms has been reserved forthe ASPL Seminar at the La QuintaResort & Club in La Quinta, California.The hotel is located at 49-499Eisenhower Drive.

Room rate is $150 plus 13.2% tax (state,local, county and tourism fee). Thespecial group rate will apply three daysbefore and after the official dates of theconference. To make your reservation,call 1-800- 598-3828. Be sure to identifyyourself with the ASPL/NAPSA meeting.The hotel reservation cut-off date isOctober 20, 2010.

A first night’s room deposit must bemade with a credit card to ensureconfirmation. Room deposits arerefundable up to three days in advanceof arrival, after which it is nonrefundable.

Directions From PalmSprings Airport (PSP)

Approximately 20 miles to theresort.Travel time is approximately 25minutes by car (45 minutes in heavytraffic).Cab fare from the airport to theresort is approximately $65-$70 +gratuity each way.Shuttle service is available. Fareranges from approximately $45-$50+ gratuity each way. There are twooptions for shuttle service: At YourService (888-700-7888) or DesertValley (800-413-3999). Rental cars are available onsite atthe airport. Note: There is a HertzRental Car office onsite at the resort.

You can also fly in to OntarioInternational Airport or Los AngelesInternational Airport. For more detailsabout transportation from these airports,go to www.aspl.org

Developments inPharmacy Law XXINovember 18-21, 2010

La Quinta Resort & ClubLa Quinta, California

American Society for Pharmacy Law 3

Thursday, November 18, 20109:00 am – 5:00 pm ASPL Board Meeting3:00 pm – 5:00 pm ASPL Registration Desk Open5:30 pm – 7:30 pm Reception ASPL/NASPA

Friday, November 19, 20107:00 am – 5:00 pm ASPL Registration Desk Open7:00 am – 8:00 am Breakfast - ASPL/NASPA8:00 am – 8:15 am Welcome Remarks ASPL/NASPA

Joint Education Sessions ASPL/NASPA8:15 am – 9:45 am DEA Update on Regulations

and EnforcementSpeaker: John Coleman, PhD, Prescription DrugResearch Center, LLC - 1.5 credit hoursThis program will: (i) provide information about recentand proposed changes to DEA regulations and policies;(ii) describe specific issues of concern including nursinghome audits, e-prescribing, permissible changes thatpharmacists can make to CII prescriptions; and (iii)discuss DEA’s current enforcement priorities.

9:45 am – 10:00 am Break

10:00 am – 12:00 pm Legislative and RegulatoryUpdate

Speaker: Brian Gallagher, B.S.Pharm., JD, Sr. VP forGovernment Affairs at APhA - 2.0 credit hoursThis annual session will provide an overview of recentlyenacted and proposed laws and regulations that affectpharmacy with an emphasis on the Patient Protectionand Affordable Care Act (PPACA) and the Health CareReform and Education Reconciliation Act (HCERA) andthe likely implementation of new regulations toimplement health care reform.

12:00 pm – 1:00 pm Lunch - ASPL

Education Sessions1:00 pm – 2:30 pm Risk Evaluation and

Mitigation Strategies (REMS)Speakers: Josephine M. Torrente, JD, Hyman, Phelps& McNamara, PC; Rekha Garg, MD, MS, Amgen Inc.- 1.5 credit hoursREMS enactment is changing the world of drugdevelopment, product marketing and healthcareprovider communications Title IX of the Food and DrugAdministration Amendments Act of 2007 (FDAAA)provides a statutory framework and authority for theFood and Drug Administration (FDA) that permits FDAto impose REMS for drugs and biologics at the time ofapproval or anytime thereafter. This session will provideon update on FDA’s REMS policy. Discussants will

Developments in Pharmacy Law XXINovember 18-21, 2010

La Quinta Resort & Club - La Quinta, California

explore how manufacturers are complying with REMSand how REMS is an integral part of productdevelopment and life cycle management, the specialissues associated with opioid REMS, REMS assessments,and the benefits and burdens of REMS on thehealthcare system, including healthcare providercommunications with patients.

2:30 pm – 3:30 pm Privacy Laws and the Effect ofHITECH Amendments to HIPAA

Speaker: Kevin Nicholson, RPh, JD, NACDS - 1 credithourThis presentation will describe the HITECH amendmentsto HIPAA and the changes required by pharmacyorganizations to comply with the breach notificationsrequirements, the expansion of jurisdiction to coverbusiness associates, and what new rules are on thehorizon.

3:30 pm – 3:45 pm Break

3:45 pm – 5:15 pm Sizzling Issues for Boards ofPharmacies

Speakers: Richard A. Palombo, Medco HealthSolutions, Inc; Mark Johnston, RPh, Idaho Board ofPharmacy; Donna Horn, RPh, DPh, Institute for SafeMedication Practices - 1.5 credit hoursThis panel will discuss issues they consider to be mostimportant and provide practical insight as to howpharmacists should address these issues to ensurecompliance. Topics will include issues such as whetherpharmacists should be represented by counsel beforeboards, evolving central fill laws, and the interplay ofstate and federal controlled substances law.

6:30 pm – 9:30 pm Reception ASPL/NASPA

Saturday, November 20, 20107:00 am – 1:00 pm ASPL Registration Desk Open

7:00 am – 8:00 am Breakfast - ASPL/NASPA

8:00 am – 10:00 am New Fraud and Abuse Issuesunder the PPACA

Speaker: Don Bell, JD, NACDS - 2.0 credit hoursThe healthcare reform law substantially changes thefraud and abuse landscape for pharmacists. Thispresentation will describe new mandatory complianceprograms for pharmacies, the expansion of pharmacyaudits and investigations, new training requirements,and practical steps pharmacies should consider.

10:00 am – 10:15 am Break

10:15 am – 11:15 am Defending Pharmacists in theFace of Federal CriminalCharges

Speaker: Robert P. Esgro, RPh - 1.0 credit hourThis presentation will cover what types of cases will mostlikely lead to a federal criminal indictment, theprocedural steps in a federal criminal case, strategies forintervening before an indictment is issued, and insightinto how to defend a pharmacist indicted for federalcrime.

11:15 am – 12:45 pm Ethical Issues for PharmacistAttorneys

Speakers: Kenneth R. Baker, RPh, JD, Ken BakerConsulting; William E. Fassett, PhD, RPh,Washington State University College of Pharmacy -1.5 credit hoursThis interactive dialogue will focus on principles andrules of the code of professional conducts applied tocircumstances surrounding the representation ofpharmacists, pharmacies, and related industries.

Sunday, November 21, 2010

7:00 am – 12:00 pm ASPL Registration Desk Open

7:00 am – 8:00 am Breakfast - ASPL

8:00 am – 9:00 am Medical Marijuana—PolicyTrends

Speaker: Diane Hoffmann, University of MarylandSchool of Law - 1.0 credit hoursThis presentation will provide an overview of thepharmacology and abuse potential for marijuana andhow the science interacts with the trends in state andfederal policy governing marijuana.

9:00 am – 9:15 am Break

9:15 am – 11:15 am Case Law UpdateSpeakers: Roger Morris, RPh, JD, Quarles & BradyStreich Lang LLP; William J. Stilling, RPh, JD, ParsonsBehle & Latimer - 2.0 credit hoursThis popular annual session reviews lawsuits, courtdecisions, and settlements from the past year that affectpharmacies, pharmacists, and others involved inpharmacy law.

Register Today at www.aspl.org

Sponsored by American Society for Pharmacy LawIn conjunction with National Alliance of State Pharmacy Associations

American Society for Pharmacy Law4

Payment Method: Check enclosed for full payment.

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LAST DAY TO PRE-REGISTER FOR SEMINAR - NOVEMBER 1

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Cancellation policy: Refund of registration (less a $50 administrative fee) willbe granted for cancellations received in writing on or before October 1, 2010. Refund of registration (less a $150 administrative fee) will be granted forcancellations received in writing after October 1, 2010 but on or beforeOctober 31, 2010. Refunds will not be granted for no-shows or cancellationsreceived after October, 31, 2010 regardless of cause. In the event of a no-showor cancellation after October 31, 2010, meeting materials will be forwarded tothe address provided on your registration form. Written cancellations mustbe emailed to dscott@associationcentral.org, or faxed to 217-529-9120, Attn:Dustin.

Developments in Pharmacy Law Seminar XXINovember 18-21, 2010

La Quinta Resort & Club - La Quinta, California

FULL CONFERENCE: By 10/08 After 10/08ASPL Member $545.00 $620.00Nonmember $675.00 $775.00Spouse/Guest $200.00 $200.00Student Tech. Paralegal $275.00 $350.00

ONE DAY REGISTRATION:ASPL Member Fri $275.00 $325.00

Sat Sun $150.00 $200.00Nonmember Fri $345.00 $395.00

Sat Sun $175.00 $225.00Student Tech. Paralegal

Fri $150.00 $180.00Sat Sun $75.00 $105.00

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Registration fee for Seminar includes attendance at all seminarsessions, breakfast, refreshment breaks, Thursday and Fridayreceptions, Friday lunch and all seminar materials.

REGISTER BY OCTOBER 8 FOR EARLY BIRD DISCOUNT

Total Fees: _________________

Register on-line at www.aspl.orgASPL is accepting on-line registrations at www.aspl.org

or, you can mail registration form to:

American Society for Pharmacy Law3085 Stevenson Drive - Suite 200 - Springfield, IL 62703

or fax to: 217-529-9120.Payment must accompany registration.

Direct registration questions to Dustin Scott atdscott@associationcentral.org or 217-529-6948

ASPL is a 501(c)(3) non-profit, voluntary professional association and all contributions are fully tax deductible. The ASPL Federal Tax ID Number is: 52-1250852.

American Society for Pharmacy Law 5

there is far too much expense and regulatorybaggage. Rather they would prefer to flourishin their own markets while making claims thathopefully do not cross the line.

And where is that line? The Food Drugand Cosmetic Act defines a drug as, amongother things, articles intended for use in thediagnosis, cure, mitigation, treatment, orprevention of disease in man or other animalsor articles (other than food) intended to affectthe structure or any function of the body ofman or other animals.4 Subsequentamendments to the Act have exempted dietarysupplements and foods from the specter ofbeing considered drugs when structurefunction claims are made. That is not to saythat there may not be therapeutic uses forprobiotics. In fact a 2005 conference that wasco-funded by the National Center forComplementary and Alternative Medicine(NCCAM) and convened by the AmericanSociety for Microbiology explored this topic,and participants concluded that there isencouraging evidence for therapeutic use ofprobiotics. Some of the possibilities include:treating diarrhea, especially when caused byrotavirus; preventing and treating infectionsof the urinary tract or female genital tract;treating irritable bowel syndrome; reducingrecurrence of bladder cancer; shortening thelength of intestinal infection caused by a

Probiotics Challenge Existing Regulatory StructuresContinued from page 1

Clostridium difficile; preventing and treatingpouchitis (a condition that can follow surgeryto remove the colon); and preventing andmanaging atopic dermatitis (eczema) inchildren.5

However, even if there is evidence of theseuses, if a manufacturer claimed that its probioticwould be useful in treating one of thesediseases, it would be making a drug claim,triggering the new drug approval process andnecessitating the need for an IND andsubsequent new drug application (NDA).While not all probiotics are dietarysupplements, allowable structure functionclaims can be observed for some of theseproducts. For example, Align® Daily ProbioticSupplement Capsules (Bifantis) labeling states:“When taken daily, Align®promotes a healthydigestive system, helping to restore your naturalbalance and giving you an ongoing naturaldefense against these occasional episodes ofdigestive upsets that can interrupt your life.”6

Other probiotic claims may raise obviousquestions. For example Dr. Ohhira’s ProbioticMagoroku Skin Care Lotion® (E. faecalis TH10strain of lactic acid bacteria) “… may be usedon bedsores, prickly heat, skin parasites,ringworm, toenail fungus, rosacea, athlete’s foot,and other skin conditions.” 7 While CandidaFreedom Probiotic Soap® (Bacillus coagulans)“… may be used from head to toe to encourage

beautiful healthy skin.”8 The first might besuggestive of a drug claim while the latter wouldappear to fall within the definition of acosmetic.

While it is beyond the scope of this articleto delve into all of the product categories andprobiotic examples, suffice it to say that thatthis is an area where the existing regulatorystructure needs to be assessed for its adequacyin dealing with probiotics.

Francis Palumbo is Professor and ExecutiveDirector of the Center on Drugs and Public Policyat the University of Maryland School ofPharmacy, and is President-elect of ASPL.

(Endnotes)1 http://www.activia.us.com/about.asp (lastaccessed 8-5-10)2 21 USC §3213 21 CFR §101.724 21 USC §321(g)5 http://nccam.nih.gov/health/probiotics (lastaccessed 8-5-10)6 http://www.aligngi.com/align-FAQ#5 (lastaccessed 8-5-10)7 http://www.drohhiraprobiotics.com/dr_ohirra_probiotic_magoroku_skin_lotion.php(last accessed 8-5-10)8 http://www.harvesthealth.com/cafrprso.html(last accessed 8-5-10)

The Washington State University College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education (ACPE) asa provider of continuing pharmacy education. Attendance at the program and submission of an attendance form will be requiredto receive continuing education credits. Certificates will be mailed to participants within 4 weeks after the meeting.

Continuing Legal Education CreditsIf you intend to apply for continuing legal education credits, please be sure to indicate the state(or states) in which you are licensed and the corresponding license number(s) on the conferenceregistration form. Quarles & Brady, LLP will process the CLE credits for the Developments inPharmacy Law Seminar.

Continuing Legal Education credit will be applied for based on attendee return of the “Legal CEParticipation Summary and Certificate of Attendance Form” at the conclusion of the seminar.

Earn up to 15 Continuing Legal and Pharmacy Education Credit HoursACPE Continuing Education Credits

American Society for Pharmacy Law6

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PAIDSpringfield, IL

Permit No. 250American Society for Pharmacy Law3085 Stevenson Drive, Suite 200Springfield, IL 62703

Editor:William E. Fassett, PhD, RPhProfessor of Pharmacy Law & EthicsWashington State Universityb.fassett@comcast.net

Contributing Editor:Roger Morris, JDQuarles & Brady, LLProger.morris@quarles.com

ASPL Business Office:3085 Stevenson Drive, Suite 200Springfield, IL 62703217-529-6948 Phone217-529-9120 Fax

BOARD OF DIRECTORS

PRESIDENT

Kimberly Burns

PRESIDENT ELECT

Frank Palumbo

TREASURER

William Fassett

IMMEDIATE PAST PRESIDENT

John Cronin

DIRECTORS

Steve Gray

Donna Horn

Mary Ellen Kleiman

William Stilling

EXECUTIVE DIRECTOR

Nathela Chataranchatara@associationcentral.org

Rx Ipsa LoquiturJuly/August 2010

©2010, American Society for Pharmacy Law

All rights reserved. No part of thispublication may be reproduced ortransmitted in any form or by any meanswithout the written permission of thecopyright holder.

Complete Board contactinformation can be found on the

ASPL website

www.aspl.org

November 18-21, 2010Developments in Pharmacy Law Seminar XXIIn Conjunction with National Alliance of State Pharmacy AssociationsLaQuinta Resort & Club - LaQuinta, California

Sponsored by American Society for Pharmacy LawRegistration is now open at www.aspl.org.

Register Today at www.aspl.org