Franck's Mentioned in Florida Department of Health Document Showing Verbal Agreement

On the Florida Department of Health, A Best Practice Submission, shows the following with regard to Franck's Pharmacy:

An anonymous donor contacted Dr. Mike Jordan, Executive Director of the Marion County Children’s Alliance, in the summer of 2007 and volunteered to establish a fund of
$4000.00 to assist medically and financially needy children in Marion County. The Marion
County Children’s Alliance is a community organization working toward providing a safe,
healthy and nurturing environment for all children. Dr. Mike Jordan, Marion County
Children’s Alliance Executive Director, contacted Barbara Timmington, RN, Marion County
Health Department School Health Supervisor, to request the assistance of School Nurses
as the referral source for financially and medically needy students. A Marion County
Health Department Standard Operating Procedure was created to determine the method
of implementation of this funding source. No money was transferred or utilized by the
Marion County Health Department staff. A referral request form was created to verify
financial need. The form indicates the medical need and justification of financial need (free
and reduced lunch). The School Nurses complete the form and fax it to the School Health
Supervisor. The School Health Supervisor conducts an investigation into cost, availability
and possible delivery to the student. A verbal agreement with a local pharmacy (Franck’s 
Pharmacy), established a cost effective supply source for medications and durable 
medical supplies with free delivery if needed. The School Health Supervisor obtains the 
lowest quoted price for the requested supply and then contacts the Pharmacy partner to 
advise quote.  The referral form with a prescription copy is faxed to the Pharmacy partner.

Click here to read entire document.

Report on Current Investigative Findings in Case Against Franck's : 33 cases in 7 states: Clinicians warned to avoid use of compounded products labeled as sterile from Franck's

Notes from the Field: Multistate Outbreak of Postprocedural Fungal Endophthalmitis Associated with a Single Compounding Pharmacy — United States, March–April 2012

Morbidity and Mortality Weekly Report (MMWR)

May 4, 2012 / 61(17);310-311
On March 5, 2012, the California Department of Public Health was notified of nine cases of clinically diagnosed fungal endophthalmitis at a single California ambulatory surgical center. The initial investigation, led by the Los Angeles County Department of Public Health, determined that in all cases patients had undergone vitrectomy with epiretinal membrane peeling using a dye called Brilliant Blue-G (BBG) from Franck's Compounding Lab, Ocala, Florida. This investigation has since expanded to involve intravitreal injection of triamcinolone-containing products from Franck's, an overall total of 33 cases in seven states, and collaboration between state and local health departments, CDC, and the Food and Drug Administration (FDA). This report describes the current investigative findings. Clinicians should be aware of the ongoing investigation and should avoid use of compounded products labeled as sterile from Franck's during this ongoing investigation.
A probable case is defined as ophthalmologist-diagnosed fungal endophthalmitis occurring in a patient who underwent an invasive ophthalmic procedure, including but not limited to vitrectomy, corneal surgery, or intravitreal injections on or after August 23, 2011, the production date of the contaminated BBG lot. Confirmed cases meet criteria for probable infection and also have fungi identified from the affected eye by culture, genetic sequencing, or histopathology. Active case-finding in this investigation has included calls for cases through Epi-X postings, FDA MedWatch alerts, ClinMicroNet microbiology laboratories, e-mails sent to all members of two professional ophthalmology societies, and state and local health alerts.
As of April 30, a total of 33 confirmed and probable cases have been identified, with earliest onset of symptoms in November 2011. Of these, 20 cases (13 probable and seven confirmed) are associated with BBG dye use, and 13 (two probable and 11 confirmed) are associated with triamcinolone use. All BBG or triamcinolone products administered to patients reportedly were purchased from Franck's. All available isolates from the seven confirmed cases associated with BBG dye use were identified by culture or genetic sequencing as the mold Fusarium incarnatum-equiseti species complex. All available isolates from the 11 confirmed cases that occurred following intravitreal injection of triamcinolone-containing products have been identified as the mold Bipolaris hawaiiensis. Both Fusarium and Bipolaris are ubiquitous molds present in air, soil, and water. Among the 30 patients for whom data are available, 23 (77%) have suffered some degree of vision loss, ranging from partial to severe, or worsened vision because of infection; 24 (80%) have required repeat ophthalmic surgery.
Culture of unopened bottles and intact (unused, pharmacy-prepared) syringes of BBG dye collected by FDA yielded multiple bacterial and fungal species, including F. incarnatum-equiseti species complex, Rhodotorula, Bullera, Pseudomonas, and Enterobacter species. Microbiologic testing of triamcinolone-containing products from Franck's is ongoing. On March 9, Franck's recalled all BBG dye lots; on March 31, a single lot of triamcinolone was recalled. The investigation to identify the root cause of product contamination is ongoing. The pharmacy has not recalled or halted production of other sterile compounded products, which, in addition to ophthalmic preparations, include chemotherapy and numerous other medications administered by injection (including intrathecal and epidural), inhalation, and intranasal routes.
Postprocedural endophthalmitis is uncommon, complicating 0.04% of either intravitreal injections or pars plana vitrectomies (1,2). The majority of these infections are bacterial; fungal infection is rare and often is diagnosed only after a patient has failed empiric antibacterial therapy. Clinicians are encouraged to be vigilant for postprocedure adverse events, particularly among patients who have received a product labeled as sterile from Franck's, and should consider methods to confirm and treat possible fungal infection.
Compounding pharmacies, which combine or alter medications from standard preparations, provide needed formulations that often are not available from pharmaceutical companies. Compounded sterile preparations must be prepared according to aseptic practices recommended by organizations such as the United States Pharmacopeia, as stated in United States Pharmacopeia-National Formulary (3). However, contamination of compounded sterile preparations has caused outbreaks. Since 1990, FDA has learned of approximately 200 adverse events associated with 71 compounded products (4). A recent outbreak of bacterial endophthalmitis following intravitreal injection of contaminated bevacizumab occurred after breaches in aseptic technique at a different compounding pharmacy (5).
Because of the seriousness of endophthalmitis and because the full extent of the outbreak and root cause of contamination remain unknown, CDC recommends that, at this time, clinicians avoid use of compounded products labeled as sterile from Franck's. Health-care providers should maintain a heightened suspicion for infections among patients who received compounded products labeled as sterile from Franck's and should report suspected infections to their local and state health departments for further investigation. Patients also should avoid use of compounded products labeled as sterile from Franck's and report adverse events or suspected infections promptly to their physician.

Reported by

Suber Huang, MD, Pravin Dugel, MD, American Society of Retina Specialists, Chicago, Illinois. George Williams, MD, American Academy of Ophthalmology. Moon Kim, MD, Kelsey Oyong, MPH, Clara Tyson, MSN, Laurene Mascola, MD, Los Angeles County Dept of Public Health. Kavita K. Trivedi, MD, California Dept of Public Health. Julie Duran, MPH, Colorado Dept of Public Health and Environment. Shannon Millay, MPH, Indiana State Dept of Health. Stephanie Black, MD, Chicago Dept of Public Health; Judith Conway, Illinois Dept of Public Health. Susanne Straif-Bourgeois, PhD, Louisiana Office of Public Health. Rick Sowadsky, MSPH, Nevada State Health Div. Ellen H. Lee, MD, New York City Dept of Health and Mental Hygiene. Tom Török, MD, Benjamin Sun, DVM, Career Epidemiology Field Officer Program, Office of Public Health Preparedness and Response; Shawn Lockhart, PhD, Julie Harris, PhD, Benjamin J. Park, MD, Div of Foodborne, Waterborne, and Environmental Diseases, National Center for Emerging and Zoonotic Infectious Diseases; Rachel Smith, MD, Christina Mikosz, MD, Raymund Dantes, MD, Yoran Grant, PhD, EIS officers, CDC. Corresponding contributors: Christina Mikosz, dex0@cdc.gov, 213-240-7941; Rachel Smith, vih9@cdc.gov, 404-639-7738.

References

1. Chen E, Lin MY, Cox J, Brown DM. Endophthalmitis after intravitreal injection: the importance of viridans streptococci. Retina 2011;31:1525–33.
2. Eifrig CWG, Scott IU, Flynn HW, Smiddy WE, Newton J. Endophthalmitis after pars plana vitrectomy: incidence, causative organisms, and visual acuity outcomes. Am J Ophthalmol 2004;138:799–802.
3. Kastango ES, Bradshaw BD. USP chapter 797: establishing a practice standard for compounding sterile preparations in pharmacy. Am J Health Syst Pharm 2004;6:1928–38.
4. Food and Drug Administration. The special risks of pharmacy compounding. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2007. Available at http://www.fda.gov/forconsumers/consumerupdates/ucm107836.htm. Accessed April 30, 2012.
5. Goldberg RA, Flynn HW, Isom RF, Miller D, Gonzalez S. An outbreak of streptococcus endophthalmitis after intravitreal injection of bevacizumab. Am J Ophthalmol 2012;153:204–8.e1.

Franck's had to Answer Why It had Not Paid Penalties

A recent article entitled Trouble ahead for Franck's, Second Drug Controversy in Three Years could Spell Problems for Ocala Compounding Law, written by Carlos E. Medina and published on May 4, 2012, points out that Franck's has not satisfied state penalties handed down in the settlement after the 2009 incident that killed the 21 horses and Franck's recently had to appear before the Florida State Board of Pharmacy to answer why it had not paid the penalties.  The articles states: 

But even as the company deals with the latest investigation, it still has not satisfied state penalties handed down in a settlement after the 2009 incident that killed the 21 horses.The Florida State Board of Pharmacy recently brought Franck's before them to answer for not paying the penalties.
On May 1, the board ordered the lab to pay more than $14,387.21 in original penalties, plus another $2,000 fine and $1,000 in administrative costs for not abiding by the first settlement. The company has 90 days to pay the fines.

In the 2009 case, Franck's was cited by the state Department of Health for numerous violations of Florida law covering pharmacies. 

To read the entire article, click here.

Settlement Agreement Between Franck's and Florida State Department of Health

A draft of the Florida State Department of Health board meeting minutes for April shows more trouble for Paul Franck and Franck Pharmacy.  To read the entire draft of the minutes, click here.  Here are the disciplinary actions against Franck.

TAB 3 DISCIPLINARY CASES – John Truitt, Assistant General Counsel
A. SETTLEMENT AGREEMENT– APPEARANCE REQUIRED CASES
A-1  Paul Wayne Franck, PS 17342, Ocala, FL
  Case No. 2008-17152 – PCP Powers/Jones
Respondent violated:
Count One:  Section 465.016(1)(e), F.S., by violating Sections 499.01(1) and 499.005(22), F.S., by failing to obtain a prescription drug wholesaler’s permit or a retail pharmacy drug wholesaler’s permit prior to engaging in wholesale distribution of prescription drugs.
Count Two:  Section 465.016(1)(e), F.S., by violation of section 499.005(22)m by failing to obtain a permit prior to operation as a prescription drug repackager as required by section 499.01(1)(b).
Respondent shall be present. Respondent shall pay a fine in the amount of $2,000 and costs in the amount of $427.17. Respondent shall complete a 12 hour Laws and Rules CE course.
Respondent was present and sworn in by the court reporter. Respondent was represented by William Furlow.
Motion: by Weizer, seconded by Fallon, to accept the Settlement Agreement. Motion carried.
A-2  Francks Lab, Inc, PH 19761, Ocala, FL
Case No. 2008-16979, 2010-16555 – PCP Powers/Jones, Garcia/Weizer
(2008-16979) Respondent violated:
Count One:  Section 465.016(1)(e), F.S., by violating Sections 499.01(1) and 499.005(22), F.S., by failing to obtain a prescription drug wholesaler’s permit or a retail pharmacy drug wholesaler’s permit prior to engaging in wholesale distribution of prescription drugs.
Count Two:  Section 465.016(1)(e), F.S., by violation of section 499.005(22)m by failing to obtain a permit prior to operation as a prescription drug repackager as required by section 499.01(1)(b).
(2008-16979) Respondent shall be present. Respondent shall pay a fine in the amount of $2,000 and costs in the amount of $750.97.

Respondent was present and sworn in by the court reporter. Respondent was represented by William Furlow.
For the first Settlement Agreement:
Motion: by Ms. Mullins, seconded by Dr. Fallon, to dismiss the case. Motion carried with Dr. Griffin opposed.
(2010-16555) Respondent violated Section 456.072(1)(k), F.S., by failing to perform any statutory or legal obligation placed upon a licensee.
(2010-16555) Respondent shall be present. Respondent shall pay a fine in the amount of $2,000 and costs in the amount of $80.67.
For the second Settlement Agreement:
Motion: by Dr. Fallon, seconded by Ms. Glass, to accept the Settlement Agreement. Motion carried.

Oral Arguments Set in Franck's case for week of October 29, 2012

The 11th Circuit Court of Appeals has set the Franck's case on the oral argument tentative calendar to be held in Atlanta during the week of October 29, 2012.  The actual date and time of the oral argument will be announced later.  As previously, discussed on this blog, here is an overview of the appellate process:

Jurisdiction of 11th Circuit Court of Appeals The Franck's case is currently pending at the 11th Circuit Court of Appeals.  I thought a short discussion of federal appellate procedure might be helpful.  The 11th Circuit Court of Appeals is a federal court with appellate jurisdiction over the district courts in the following districts: 1.  Middle District of Alabama 2.  Northern District of Alabama 3.  Southern District of Alabama 4.  Middle District of Florida 5.  Northern District of Florida 6.  Southern District of Florida 7.  Middle District of Georgia 8.  Northern District of Georgia 9.  Southern District of Georgia What the 11th Circuit Can Consider A federal appellate court is generally only allowed to consider the record that was established in the district court.  There are some exceptions, but for the most part if the evidence or information was not presented in the district court then the 11th Circuit will not be allowed to consider it on appeal.  The same principle generally applies to legal arguments made on appeal.  If the argument was not made in the district court, there is a strong chance it will be considered waived or forfeited on appeal.  Again there are exceptions. Oral Argument Once briefing is done in Francks, the case will be submitted to a panel of three judges to review the district court decision. Approximately three-fourths of the court's cases are decided on the briefs submitted by the parties, while the remaining cases include oral argument. Oral arguments are held in the Elbert P. Tuttle United States Court of Appeals Building in Atlanta, Georgia and are open to the public. Oral arguments are also held in Florida (Jacksonville and Miami) and Alabama (Montgomery). Most likely in Franck's the judges will set the case for oral argument because the parties have requested oral argument.  Each side's attorneys will get 15 minutes to argue the position of the party represented.  The amicus curiae who filed briefs in the Franck's case may participate in oral argument only with the court's permission. Timing of Decision After oral argument, the appellate court will issue a decision.  There is no time limit on when the decision has to be issued.  Some cases can take over a year before an appellate court issues its opinion. The Written Opinion The opinion will consist of a written analysis that reviews the district court's decision.  The appellate court can (1) affirm the district court decision; (2) reverse the district court decision; (3) modify the district court decision or (4) remand the case for further the district court to make further factual findings.  This decision will be binding only in the states listed above that make up the 11th Circuit Court of Appeals.  It will be persuasive authority in all other states, but those federal courts will not be bound by the decision and can reach a totally contrary result if presented with the issue.  Only if the issue is decided by the United States Supreme Court will the decision be binding in all federal courts. Options of Losing Party At that point, the losing party can file a (1) petition for rehearing before the three judge panel, (2) file a petition for rehearing en banc before the full 11th Circuit Court of Appeals (3) petition for certiorari to the United States Supreme Court or (4) accept the decision and implement whatever it says.  A court of appeals is not required to grant a petition for rehearing before the three judge panel or before the full court.  Furthermore, the United States Supreme Court would not be required to grant certiorari.  Each of the first three options has different legal standards that must be met.

Franck's Compounding Lab: Notice of Recall - Triamcinolone acetonide P.F. 80mg/ml

These recalls relating to Franck's Compounding Lab were issued on March 31, 2012, and May 1, 2012

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Notice of Recall - Triamcinolone acetonide P.F. 80mg/ml

Contact:
Jim Kilbride, RPh
Pharmacist-in-Charge
Franck’s Compounding Lab
1210 SW 33rd Ave. Ocala, FL 34474
352-622-2913
Fax: 352-690-6770

May 2, 2012

Dear Physician,

Franck’s lab recently had a fungal issue with one lot of triamcinolone acetonide P.F. 80mg/ml and on March 29, 2011 instituted a recall. The recall involved five physicians and eight prescriptions. The physicians have been contacted and all prescriptions accounted. As a precaution Franck’s Lab has recalled one additional lot of triamcinolone acetonide P.F. 80mg/ml. No adverse events have been reported related to this lot. The recall involved four physicians and five prescriptions. All offices have been contacted. If you have any concerns or questions regarding a prescription of triamcinolone acetonide or product containing triamcinolone acetonide received from Franck’s do not hesitate to contact us.

Regards,
Jim Kilbride, RPh
Pharmacist-in-Charge
Franck’s Compounding Lab
1210 SW 33rd Ave. Ocala, FL 34474
352-622-2913
Fax: 352-690-6770

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

NOTICE OF RECALL

Contact:
Jim Kilbride, RPh
Pharmacist-in-Charge
Franck’s Compounding Lab
1210 SW 33rd Ave. Ocala, FL 34474
352-622-2913
Fax: 352-690-6770

March 31, 2012

Dear Physician
Franck’s lab recently had a fungal issue with one lot of triamcinolone acetonide P.F. 80mg/ml and instituted a recall. The recall involved five physicians and seven prescriptions. The physicians have been contacted and all prescriptions accounted. If you have any concerns or questions regarding a prescription of triamcinolone acetonide or product containing triamcinolone acetonide received from Franck’s do not hesitate to contact us.

Regards,
Jim Kilbride, RPh
Pharmacist-in-Charge
Franck’s Compounding Lab
1210 SW 33rd Ave. Ocala, FL 34474
352-622-2913
Fax: 352-690-6770

###

More on FDA's recall of Franck's Brilliant Blue G

More information regarding the FDA's recall of Brilliant Blue G-Dye can found in this news article entitled, Eye infections linked to Ocala's Franck's Compounding Lab.  Click here to read article.

DOJ/FDA reply to Franck's and Amici Waiver Argument

In addressing the waiver argument raised by Franck's and amici, DOJ/FDA contends:

The government's brief cites numerous instances in the record where it argued and documented that the factual basis of this action for injunctive relief is that Franck's animal drug compounding activities exceed the bounds of traditional pharmacy compounding and are indicative of large-scale drug manufacturing, as described in CPG 608.400.

DOJ/FDA also explains that this case involves a question of law--not the specific facts--of the case.  It  states,  "To be sure, the fundamental issue in this case is a question of law, the resolution of which depends on analysis of the FDCA, not on any specific facts."  Nonetheless, DOJ/FDA argues it is both necessary and logical to discuss FDA's enforcement policy and application of that policy to the facts on which the complaint for injunctive relief was based.  DOJ/FDA argues it has not waived the argument because it has not belatedly raised a new theory.  More specifically, its brief contains the following argument:

Contrary to Franck's claims, the government has not belatedly raised an "alternative theory" of its case – that compounded animal drugs are unlawful only when prepared in an operation resembling manufacturing. There is but one theory of this case: New animal drugs compounded by pharmacies are not exempt from the FDCA and never were, and they are accordingly subject to FDA's enforcement authority. However, FDA recognizes that compounded animal drugs can serve beneficial public health purposes. Thus, pursuant to its consistent, longstanding policy, FDA undertakes enforcement action against compounding pharmacies only when the scope and nature of their activities "raise the kinds of concerns normally associated with a drug manufacturer and result in significant [FDCA] violations." CPG 608.400, Doc. 17-2, Ex. A at 4. Because Franck's animal drug compounding operations raise such concerns, the government brought this action to enjoin Franck's further violations of the Act. That has been the government's position throughout this litigation. 

Ultimately, DOJ/FDA contends that government counsel's previous comments at the district court level are not sufficient to show waiver:

Citing excerpts from government counsel's responses to questions during district court oral argument, Franck's Lab contends further that FDA has waived certain other arguments, e.g., the relevance of AMDUCA and other FDCA provisions to the statutory interpretation question at issue. As FDA's opening brief notes (at 41 & n.15), government counsel's comments do not support Franck's waiver claim. Moreover, this Court has held that "waivers and concessions made in appellate oral arguments need to be unambiguous before they are allowed to change the outcome of an appeal," and such comments should be considered in the context of the party's briefs and entire presentation. Crowe v. Coleman, 113 F.3d 1536, 1542 (1997). See also Moose Lodge v. Irvis, 407 U.S. 163, 170, 92 S. Ct. 1965, 1970 (1972) ("We are loath to attach conclusive weight to the relatively spontaneous responses of counsel to equally spontaneous questioning from the Court during oral argument."). That same principle should apply to counsel's comments during district court arguments.Thus, considering the government's complaint, arguments in support of its motions for a preliminary injunction and summary judgment, declarations, and other evidence, snippets of government counsel's argument in district court cannot reasonably be construed as concessions or waivers of any legal arguments. Cf. Savoury v. U.S. Attorney General, 449 F.3d 1307, 1318-19 (11th Cir. 2006) (even if estoppel applies to government, willfulness and negligence, inter alia, must be shown). 

Summary in DOJ's Reply Brief in Franck's

Here is the introduction and summary from the government's reply brief in Franck's:

INTRODUCTION AND SUMMARY 

    Like the definition of "new drug" for human use, the definition of "new animal drug" in the Federal Food, Drug, and Cosmetic Act ("FDCA" or "the Act") is sweeping and straightforward – "any drug intended for use for animals other than man" that "is not generally recognized * * * as safe and effective under the conditions prescribed." 21 U.S.C. § 321(v)(1) (emphasis added); compare id. § 321(p)(1) ("new drug" definition). When a pharmacy compounds a drug for animal use, it creates a Case: 11-15350 Date Filed: 05/01/2012 "new animal drug" because the compounded product is not generally recognized by experts as safe and effective, and it has not been subjected to the controlled clinical trials that are necessary to establish its safety and effectiveness. Even a drug that is a copy of an approved animal drug is a "new animal drug" that must be independently established as safe and effective when produced by a party other than the one that holds FDA approval for the drug. Although Congress has carved out a few exceptions to the "new animal drug" definition and the FDCA's approval and other requirements for such drugs, it has enacted no unconditional exemption for new animal drugs compounded by pharmacies.   

     Thus, the consistent position of the Food and Drug Administration ("FDA" or "the agency") – based on the Act's plain language and documented in litigation, FDA's Compliance Policy Guides ("CPG"), and regulations – has been that pharmacy-compounded drugs for human and animal use are "new drugs" and "new animal drugs" that require FDA approval before they can be lawfully distributed in interstate commerce.  At the same time, however, FDA recognizes that drug compounding is part of traditional pharmacy practice, and, when compounded pursuant to valid prescriptions for individual patients, compounded drugs can serve important public health purposes by meeting the needs of patients for whom approved, commercially available drugs are inadequate. For that reason, FDA has 2 Case: 11-15350 Date Filed: 05/01/2012 historically declined, and continues to decline, to take enforcement action against pharmacies engaged in traditional compounding activities. However, when evidence shows (as in this case) that a pharmacy's activities substantially exceed the bounds of traditional compounding, and the pharmacy is effectively engaged in drug manufacturing masquerading as compounding, without compliance with FDCA approval and other requirements, the agency takes enforcement action. 

     Three other circuits have squarely held that pharmacy-compounded animal drugs are "new animal drugs" under the Act and are therefore subject to FDA's enforcement authority. Med. Ctr. Pharmacy v. Mukasey, 536 F.3d 383, 408 (5th Cir. 2008) ("Medical Center"); United States v. Algon Chem. Inc., 879 F.2d 1154, 1158, 1160 (3d Cir. 1989); United States v. 9/1 Kg. Containers, 854 F.2d 173, 179 (7th Cir. 1988), cert. denied, 489 U.S. 1010, 109 S. Ct. 1118 (1989). No circuit has held otherwise.  Moreover, the Supreme Court has discussed approvingly FDA's enforcement policy and affirmed that "the Government needs to be able to draw a line between small-scale compounding and large-scale drug manufacturing." Thompson v. W. States Med. Ctr., 535 U.S. 357, 361-63, 370, 122 S. Ct. 1497, 1501-02, 1505 (2002) ("Western States"). 

     This appeal presents the same fundamental question of law answered by the courts in Medical Center, Algon, and 9/1 Kg. That question arises in the context of 3 Case: 11-15350 Date Filed: 05/01/2012 a rare civil enforcement action initiated by FDA against a pharmacy whose compounding activities have demonstrably exceeded the bounds of traditional pharmacy practice and resemble large-scale drug manufacturing. The undisputed record supporting FDA's request for injunctive relief (largely overlooked by the district court) shows that the animal drug compounding activities of Franck's Lab – as its name, extensive product catalog, operations, and documented history of FDCA violations over several years suggest – is more indicative of a manufacturer than the corner drugstore that compounds a lifesaving medication for the family dog pursuant to a veterinarian's individualized prescription. 

    Thus, this case is not about whether traditional pharmacy compounding can serve important public health purposes; it can and does. This appeal concerns whether Congress has authorized FDA to take enforcement action against pharmacies when their compounding activities pose a threat to public health because they are manufacturing drugs, but evading the FDCA's approval and other requirements that Congress enacted to protect public health. 

     Franck's Lab acknowledges, as it did in district court, that FDA has authority to take enforcement action against entities engaged in unlawful drug manufacturing, but it fails to identify the source of that authority and to explain where the "line between small-scale compounding and large-scale drug manufacturing" lies. Western 4 Case: 11-15350 Date Filed: 05/01/2012 States, 535 U.S. at 370, 122 S. Ct. at 1505. Those failures are fatal to Franck's Franck's Lab and its amici grossly misrepresent FDA's position (see, e.g., Franck's Br. 10), characterizing it as extreme, when, in fact, this action represents a judicious exercise of the agency's enforcement authority against a pharmacy that has repeatedly flouted the law and FDA warnings. 

     

     Franck's Lab and its amici contend that FDA has changed its policy and has acted inconsistently. Not so; the agency's position here is fully consistent with the position that it has repeatedly taken in other litigation over many decades and that is set forth in FDA's publicly available enforcement guidance. Franck's Lab claims that the federal government's action here clashes with sovereign State interests, but, notably, Franck's Lab has not, and cannot, identify any such tension. Finally, Franck's claim that the government has conceded or waived certain arguments is baseless.

DOJ's Reply Brief in Franck's

The government's reply brief in Franck's has been filed.  Click here to view brief.

FDA issues Second Warning regarding Compounded Drugs (Brilliant Blue G and Triamcinolone) from Franck's

Certain Compounded Drugs from Franck's: FDA Issues Second Warning to Physicians

• Brilliant Blue G (BBG)
• Triamcinolone

[Posted 04/20/2012]
AUDIENCE: Eye Care, Family Practice, Pharmacy
ISSUE: FDA has received additional reports of fungal endophthalmitis (eye infections) in patients who were given Brilliant Blue G (BBG) during eye surgery since the FDA Warning to Physicians was posted on March 19, 2012. The agency has also recently received reports of eye infections in patients who were given injections of drug products containing triamcinolone during eye surgery.
BACKGROUND: Clinicians in several states reported the adverse events. FDA, CDC, and local and state public health agencies are actively investigating these incidents.
These drugs were supplied by Franck’s Pharmacy in Ocala, Florida. Brilliant Blue G is not an approved drug in the United States. Franck’s has recalled all lots of BBG and one lot of Triamcinolone Acetonide P.F
RECOMMENDATION: The Centers for Disease Control and Prevention (CDC) has advised healthcare personnel to stop use of all sterile triamcinolone-containing products purchased from Franck’s until further information regarding the safety of these products is available.
FDA requests that practitioners report to FDA any cases of suspected fungal or bacterial infections, which have occurred within the last six months, associated with drugs labeled as sterile from Franck’s Pharmacy:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm¹
• Download form² or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[04/20/2012 - Updated Warning³ - FDA]
[03/31/2012 - Press Release⁴ - Franck’s Compounding Lab]

Previous MedWatch Safety Alert

[03/19/2012⁵]

- 

FDA Foods and Veterinary Medicine Program Strategic Plan for 2012 – 2016 Draft Targets Illegal Compounding

A draft of the FDA Foods and Veterinary Medicine Program Strategic Plan for 2012 – 2016 indicates that a new enforcement strategy to address illegal compounding of new animal drugs may be a top priority of the FDA in the future.  Cases such as Franck's and ApothCure (although not a case involving animal drugs) suggest that illegal compounding of drugs has already become a key initiative of the FDA.  The draft reads:

The FVM Program is concerned about the number of unapproved animal drug products
that are being sold and marketed to animal owners and veterinarians. To reduce the risk of
harm from substandard and illegally marketed animal drugs, the program will identify new
regulatory frameworks and enforcement strategies to combat this growing area of
concern.
Key Initiatives
7.2.1: Develop risk‐based frameworks that assure quality and safety for products
that are currently being marketed without FDA approval
7.2.2:  Develop and implement an enforcement strategy that addresses the illegal
compounding of new animal drugs and removes unsafe, ineffective or copycat
animal drugs from the market

To read the entire FDA Foods and Veterinary Medicine Program Strategic Plan for 2012-2016 click  here.

Declarations Filed in Franck's district court proceeding

In the appeal to the 11th Circuit in the Franck's case, the court, pursuant to the federal appellate rules, is normally only allowed to consider what was part of the record in the district court. In other words, the appellate court cannot consider evidence or information that was not presented in the district court.  In the district court, the parties filed a number of declarations or sworn statements by various individuals, including the following:

Declaration of Loyd V. Allen, Jr.

Declaration of Shelton T. Bradshaw

Declaration of  Gigi S. Davidson

Declaration of William T. Flynn

Declaration of Paul W. Franck

    Supplemental Declaration of Paul W. Franck

Declaration of Rick Pelphrey

Declaration of Kenneth Pettengill

Declaration of James B. Powers

Declaration of Dr. Robert C. Saunders

Declaration of Emma Singleton

Declaration of Kevin Stoothoff

Because these declarations were all apart of the record in the district court, they are part of the record on appeal and can be considered by the appellate court.

Criminal Charges in a Compounding Case: Exercise of Federal Authority

The Criminal Information filed against ApothéCure, a major compounder in the United States, and Gary D. Osborn charges violations of 21 U.S.C. Section 331(a), 352(a) and 333(a)(1)--all criminal, class A misdemeanors.  Basically, the information charges that  ApothéCure and Gary D. Osborn introduced in interstate commerce a misbranded drug in that its label was false and misleading.  Criminal misdemeanors under the federal system are criminal offenses eligible for terms of imprisonment that do not exceed one year but are more than six months in length by federal statute. See 18 U.S.C. 3559(a)(6)  Under the federal system, the district court also uses the advisory United States Sentencing Guidelines to determine the range and actual punishment.  Both the criminal charges in ApothéCure and the attempt to obtain an injunction in Franck's show the FDA and DOJ attempting to exercise its federal jurisdiction to regulate and punish compounders who step out of bounds.  It will be interesting to see how far the federal courts allow the FDA and DOJ  to exercise this power against other compounders who violate the law.   The appeal  in Franck's while only binding on those states in the 11th Circuit Court of Appeals--Alabama, Florida, and Georgia--will be precedent setting with the possibility, no matter the outcome, of making its way to the United States Supreme Court.  The other possibility if DOJ/FDA loses the appeal is for there to be a legislative fix attempting to define the parameters of federal jurisdiction to regulate this area of the law.

Links to Amicus Curiae Briefs

The following organizations have filed amicus curiae briefs or "friend of the court briefs" (parties who can show they have an interest in the outcome of the appeal) in the Franck's case at the 11th Circuit Court of Appeals.

1.  Animal Health Institute filed a brief of amicus curiae supporting the United States position and reversal of the district court's decision.

2.  The Generic Animal Drug Alliance filed a brief of amicus curiae supporting the United States' position and reversal of the district court's decision.

3.   The Washington Legal Foundation filed a brief of amicus curiae  supporting Franck's and the affirmance of the district court’s decision.