Source: http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2014/03/index.html
Timestamp: 2017-09-22 15:36:01
Document Index: 38007575

Matched Legal Cases: ['§ 360', 'art 1040', 'art?\n29', 'art 182', '§ 505', '§ 505', '§ 505', '§ 505', '§ 320', '§ 505', '§ 505']

FDA Law Blog: March 2014
Court of Appeals Affirms District Court’s Denial of Preliminary Injunction against COOL Regulations
The U.S. Court of Appeals for the District of Columbia Circuit recently declined to stop USDA/AMS implementation of the amended Country of Origin Labeling ("COOL") regulations for beef, pork, and poultry products requiring identification of the country where the animals are born, raised and slaughtered and preventing commingling. The amended COOL regulations were issued in May 2013 (see our previous post here). USDA gave industry until November 2013 to comply. The American Meat Institute ("AMI") and others filed a complaint and request for preliminary injunction, which was denied by the district court. On appeal, AMI claimed that USDA’s amended regulations were outside the Agency’s authority under the COOL statute and violated the First Amendment. They further claimed that the rule merely satisfied consumers’ curiosity. The Court of Appeals affirmed the district court's decision that “AMI [was] unlikely to succeed on the merits of its claims.”
Even if there is no appeal, the appellate decision is not the end of the road for controversy over COOL. The World Trade Organization ("WTO") already found that an earlier version of COOL was a trade barrier. The new COOL requirements allegedly are more onerous than the first, and Canada and Mexico are back at the WTO (see here). A WTO decision is expected in summer 2014.
Posted at 10:17 PM in Foods, Foods and Dietary Supplements | Permalink | Comments (0)
Evaporated Cane Juice Case Evaporates (For Now)
A putative class action targeting certain food products that declare “evaporated cane juice” (ECJ) as an ingredient was recently stayed based on the doctrine of primary jurisdiction. As noted by the Court, prior decisions have gone both ways on the question of whether deferral under the primary jurisdiction doctrine is appropriate in cases alleging that the use of “evaporated cane juice” as an ingredient name is false and misleading. What makes this decision noteworthy is its reliance on the fact that FDA recently reopened the comment period on its 2009 Draft Guidance, titled Ingredients Declared as Evaporated Cane Juice. The Court explained:
Leaving aside the question of whether the Court can properly determine, in the first instance, if ECJ is or is not the “common or usual name” of this ingredient, the FDA’s action clearly indicates that the agency is exercising its authority in this area. In light of the fact that FDA has revived its review of the ECJ issue, the Court finds that the FDA’s position on the lawfulness of the use of that term is not only. . . “not settled,” it is also under active consideration by the FDA. Any final pronouncement by the FDA in connection with that process almost certainly would have an effect on the issues in litigation here.
The Court stayed the action until August 1, at which time it expects an update from the parties on the status of FDA’s action. It remains to be seen whether other courts presiding over similar lawsuits will follow the Court’s lead.
Posted at 10:26 PM in Foods | Permalink | Comments (0)
Like Spring, GMA Science Forum is Just Around the Corner
GMA Science Forum 2014 kicks off on April 6 in Washington, DC. The Forum will feature numerous sessions addressing scientific and regulatory issues of interest to the packaged food industry. A complete agenda is available here. HPM attorneys will help present a half-day introduction to food law using a case-study approach that will cover (1) evaluating the regulatory status of ingredients and products, (2) securing supply chains and adhering to manufacturing requirements, (3) developing product labeling and advertising, (4) anticipating and responding to crises, and (5) managing relationships with regulators. We’re also participating in a half-day session on administration of the GRAS exception. Registration is available here.
Posted at 03:02 PM in Foods, Foods and Dietary Supplements | Permalink | Comments (0)
On March 25, 2014, FDA issued a proposed rule amending the regulations for classification and reclassification to conform to the changes to the Federal Food, Drug, and Cosmetic Act (the Act) made by the Food and Drug Administrative Safety and Innovation Act (FDASIA). 79 Fed. Reg. 16252 (Mar. 25, 2014). Under Section 513(e)(1)(A)(i) of the Act, FDA may, based on new information, reclassify a device by administrative order (as opposed to the pre-FDASIA requirement of reclassification by regulation) and revoke any related regulation or requirement in effect under a PMA approval order. FDA may undertake such reclassification on its own initiative or upon request from an interested person. 21 U.S.C. § 360c(e)(1)(A)(i). The post-FDASIA statutory procedures have made it easier to reclassify medical devices (see our prior post here).
Posted at 09:19 PM in Medical Devices | Permalink | Comments (0)
Game On! The HP&M Crossword Puzzle
Earlier this week we gave a “Coming Soon” announcement about a forthcoming posting of an FDA-related crossword puzzle written by Jeffrey N. Gibbs and Etan J. Yeshua as part of a celebration of Hyman, Phelps & McNamara, P.C.’s 34th anniversary earlier this month. Well, it’s here – game on folks!
Below is the crossword puzzle, followed by the clues to completing it. You can also download a PDF copy of the puzzle here (see the Note below). We’re posting this at Noon (Eastern Time) on Wednesday, March 26th. Contestants have 48 hours to complete the crossword puzzle – until Noon (Eastern Time) on Friday, March 28th – and submit their results to us. Completed puzzles can be emailed to Mr. Gibbs at jgibbs@hpm.com. Good luck! And have fun!
We’ll update this post later on Friday with the crossword puzzle answers. Everyone who submits a correct set of answers will be congratulated with a coveted HP&M Crossword Puzzle certificate. The first one to submit a correct set of answers will receive a special HP&M Crossword Puzzle certificate commemorating the accomplishment.
1. Cartoon explorer
5. Beat handily
9. Tally at the end of an Advisory Committee
14. _____ Pharmaceuticals (recently acquired Dublin-based company)
15. Year: Lat. (NOTE: Mea culpa. This clue was changed from "Years: Lat." to "Year: Lat.")
16. What a 19-Across does with photons
17. Sought-after agency designation
19. A Part 1040 product
20. Sought-after agency designation
21. Animal regulated as a medical device
23. More festive, as apparel
24. Invokes section 302
28. Some preclinical subjects
30. ___ Mack (long-serving manager)
31. Sec. 502(g) compendium
34. Boy band started in 1995
37. Popular OTC IVDs
38. Confirmed Agency official?
42. Attorney William who signed the Articles of Confederation in 1778
43. Like some dealings or figures
44. Also
45. Demand
48. Hoppers down under
50. Atlanta and Boston District Offices, e.g.
53. _____ Harbor
57. First line of a letter from President McKinley, maybe
58. Former Director of DDMAC and FDLI Chair ________ Baylor Henry
59. Offer before “Buckle up.”
62. Like an FDA-approved drug
64. Blender setting
65. Reviewer of an academic paper
66. With 63-Down, ever-increasing Agency cost
67. Hon. title of honor for some priests
68. Arbor Day honoree
69. Destinations of individuals under section 333?
1. Remove condensation, as on a windshield
2. Ugandan attorney and political leader Otunnu
4. National_____
6. Chemical consisting of A, C, G and U
7. “Let me go!”
8. Some Sec. 890.5370 devices
9. Sphygmomanometer feature, often
10. FDA regional office located on John Galt Blvd.
11. “___ healthy to be sick sometimes.” – Henry David Thoreau
12. Summer in Paris
13. Ukr., formerly
18. Designer Tarantino
22. List ender
24. Syndrome on a bottle of aspirin
25. Comment, as to a proposal
26. FDA-approved angina treatment, for short
27. Directive to a top FDA official to depart?
29. Sponsor’s post-trial document: Abbr.
31. 1921 Fritz Lang film, “Vier ___ Frau”
32. Steam room
33. The Gray Sheet and FDA News, for example, with “the”
35. High degree
36. Organization ______
39. Containing more particulate matter
40. Hoopla
41. Like some people treated by 19 across
46. Scottish treats
47. FDA summary of physical/functional result, e.g., QOL
49. Parodied
51. Expert
52. Like a drug with fewer side effects
54. Plant listed in Part 182
55. In two
56. Gawks naughtily
59. Largest FDA specialty firm
60. Sold in the UK and Aus., e.g.
61. Czech dest.
63. See 66-Across
Thank you to all of our contestants. We received many entries - several with the puzzle solution. The first person to submit a correct puzzle solution, and the recipient of the special HP&M Crossword Puzzle certificate, is: Steven Lawrie, MS, MA. The puzzle solkution is below.
Posted at 12:00 PM in Miscellaneous | Permalink | Comments (0)
Limitations Imposed on Use of FDA Warning Letters
The Supreme Court of Arkansas recently overturned (here and here) a lower court’s $1.2 billion award to the State of Arkansas, and also reversed and remanded the decision granting over $200 million in attorney’s fees and costs to the state. Putting aside the huge dollar figures at stake for Johnson & Johnson, the defendant, what makes this decision interesting for FDA Law Blog followers is the court’s opinion limiting the use of FDA’s Warning Letter as evidence. While this litigation involved allegations specific to the state’s false claims act and consumer fraud statute, the implications potentially reach beyond the State of Arkansas or these legal theories.
At trial against J&J, the State of Arkansas relied heavily on a 2004 Warning Letter issued to Janssen Pharmaceutica, Inc., the J&J unit responsible for marketing Risperdal, an antipsychotic drug. FDA objected to a “Dear Healthcare Provider” letter that Janssen had sent in 2003, claiming Janssen failed to disclose certain information contained in the product labeling, minimized the risk of certain adverse events, failed to recommend regular monitoring to identify adverse events, and misleadingly claimed that Risperdal is safer than other atypical antipsychotics. Janssen attempted to convince FDA to the contrary, but ultimately sent a corrective letter to the recipients of the “Dear Healthcare Provider” letter. FDA closed the matter six months after the Warning Letter was issued.
At trial, the State of Arkansas claimed the Warning Letter supported its position that Janssen had violated the Arkansas Medicaid Fraud False Claims Act and the Arkansas Deceptive Trade Practices Act. Indeed, the State referred to the Warning Letter repeatedly throughout the trial, and mentioned it at least 15 times during closing arguments alone.
On appeal, Janssen argued that the circuit court wrongly allowed Arkansas to use the Warning Letter as evidence, claiming it was inadmissible hearsay under the state’s rules of evidence. Hearsay is generally inadmissible unless subject to a specified exception. Here, the issue for the court was whether the Warning Letter was a public record containing factual findings resulting from an investigation made “pursuant to authority granted by law,” (admissible), or whether the factual findings resulted from a “special investigation of a particular complaint, case, or incident,” (inadmissible). Primarily relying on FDA’s language in the Warning Letter itself and the closeout letter it issued, the supreme court found that the Warning Letter stemmed from a special investigation of the Dear Healthcare Provider letter, and was not part of FDA’s routine recordkeeping authority. Therefore, the court concluded that the Warning Letter was inadmissible hearsay.
The dissent disagreed that FDA conducts a “special investigation” every time it issues a Warning Letter, focusing on the stated mission of FDA’s Division of Drug Marketing, Advertising and Communication’s (“DDMAC”), the predecessor to FDA’s Office of Prescription Drug Promotion. Because the office was created to monitor and surveil prescription drug advertising, the dissent stated that “it appears that the warning letter was merely the result of the agency’s routine duties of reviewing and regulating the information on, and advertising of, drugs such as Risperdal.” Slip op. at 29.
The majority also discussed the unfair prejudice resulting from the Warning Letter: “Reports issued by governmental agencies, because of their ‘official’ nature, may well carry inordinate weight in the minds of jurors.” Slip op. at 26 (quoting Boude v. Union Pac. R. Co., 277 P.3d 1221, 1225 (Mont. 2012)). The court concluded that the Warning Letter was more prejudicial than probative, and thus inadmissible even if it met the public records exception for hearsay evidence.
For jurisdictions that have rules of evidence excluding “special investigations” like Arkansas (for example, Delaware, Indiana, Louisiana, and Montana, to name a few), the Arkansas Supreme Court’s analysis may be persuasive. For those states without similar exceptions, however, the ruling still may be helpful in its findings related to the prejudicial nature of FDA’s Warning Letters. Because the court’s analysis was wholly independent of the underlying statutory basis for the litigation, it also could impact other types of cases involving FDA-regulated products. Several amicus briefs were filed by interested parties, including Washington Legal Foundation and Allied Educational Foundation, Pharmaceutical Research and Manufacturers of America, Public Citizen, AARP, the Arkansas Chamber of Commerce, a former FDA Commissioner, and 34 states.
Posted at 10:41 PM in Enforcement, Prescription Drugs and Biologics | Permalink | Comments (0)
Posted at 07:28 PM in Hatch-Waxman, Prescription Drugs and Biologics | Permalink | Comments (0)
FDA Expands Electronic Safety Reporting for Animal Food
FDA announced that it has implemented a new electronic reporting tool for livestock animal food problems, which the agency refers to as the Livestock Food Reporting Portal. Essentially, the portal expands the categories of reports that can be submitted through the Safety Reporting Portal, which is used for reporting a range of potential safety issues to FDA and NIH. That portal will now accept reports about foods made for livestock from veterinarians, livestock producers, and other consumers.
Expansion of electronic reporting should help FDA better detect and respond to potential safety issues associated with food for livestock. In its instructions for submission of such reports, FDA asks for a description of the problem (e.g., “foul odor, off color, inconsistent texture”), information on any clinical signs of illness, and contact information for the treating veterinarian.
Below is a list of the types of reports currently accepted through the Safety Reporting Portal:
Reportable Food Registry Report (mandatory): A food facility or responsible party that manufactures, processes, packs, or holds foods who is submitting a reportable food report.
Reportable Food Registry Report (voluntary): A federal, state, or local public health official who is submitting a reportable food report involving human and/or animal food.
Pet Food Report: A veterinarian or veterinary staff member who is submitting a product problem and/or adverse event report involving pet food.
Pet Food Report: A consumer or concerned citizen who is submitting a product problem and/or adverse event report involving pet food.
Livestock Food Report: A veterinarian or other professional who is submitting a product problem and/or adverse event report involving livestock food.
Livestock Food Report: A consumer or concerned citizen who is submitting a product problem and/or adverse event report involving livestock food.
Animal Drug Report: A marketing authorization holder (manufacturer) for an animal drug who is submitting a report on a product problem and/or an adverse event.
Tobacco Product Report: A healthcare professional submitting a product problem and/or health-related problem report involving a tobacco product.
Tobacco Product Report: A consumer or concerned citizen who is submitting a product problem and/or health-related problem report involving a tobacco product.
Dietary Supplement Report(mandatory): A dietary supplement manufacturer, packer, or distributor who is submitting a mandatory serious adverse event report.
Dietary Supplement Report (voluntary): A consumer, concerned citizen, or healthcare professional who is submitting a report about an illness, injury, or product problem associated with dietary supplement(s), or a manufacturer, packer, or distributor who is submitting a dietary supplement voluntary adverse event and/or product problem report.
Gene Research Study Report: A clinical trial primary investigator or researcher who needs to report an adverse event involving a gene research study.
Posted at 01:53 AM in Animal Drugs and Feeds | Permalink | Comments (0)
Perrigo Sues FDA Over Failure to Grant Therapeutic Equivalence Rating for Testosterone Gel 505(b)(2) NDA
In a Complaint filed last Friday in the U.S. District Court for the District of Columbia, Perrigo Israel Pharmaceuticals Ltd. and Perrigo Company (collectively “Perrigo”) (represented by Hyman, Phelps & McNamara, P.C.) allege that FDA has shirked a duty under the Federal Food, Drug, and Cosmetic Act (“FDC Act”) by failing to timely act to update the Orange Book to add a Therapeutic Equivalence (“TE”) rating for Perrigo’s Testosterone Gel, 1%, drug product approved under NDA No. 203098. FDA approved NDA No. 203098, submitted pursuant to FDC Act § 505(b)(2), well over a year ago on January 31, 2013. According to Perrigo, FDA “had an obligation at that time to update the Orange Book with a TE rating for Perrigo’s Product,” but “despite repeated requests by Perrigo to FDA asking the Agency to publish a TE rating for Perrigo’s Product, and despite publishing TE ratings for numerous other drugs approved after Perrigo’s Product, FDA has not fulfilled its statutory obligation.” FDA determined Perrigo’s drug product to be bioequivalent to the listed drug relied on for approval, namely ANDROGEL (testosterone gel) 1%, based on data and information contained in Perrigo’s NDA. Perrigo’s drug product is also pharmaceutically equivalent to ANDROGEL.
Under FDC Act § 505(j)(7)(A)(i), FDA is required to publish in the Orange Book three distinct pieces of information:
While each subsection of FDC Act § 505(j)(7)(A)(i) imposes a discrete nondiscretionary statutory duty on FDA, only the latter two subsections – and specifically the third subsection – are at issue in Perrigo’s Complaint.
FDA has stated on several occasions that the Agency fulfills the statutory duty at FDC Act § 505(j)(7)(A)(i)(III) through the use of TE codes in the Orange Book. See, e.g., 54 Fed. Reg. 28,872, 28,911 (July 10, 1989); 21 C.F.R. § 320.24(a); FDA Petition Response, Docket No. FDA-2012-P-0499, at 7-10 (Nov. 13, 2012); FDA Petition Response, Docket No. FDA-2006-P-0346, at 36-40 (Aug. 22, 2012). Under FDC Act § 505(j)(7)(A)(ii), “[e]very thirty days after the publication of the first list under clause (i),” FDA is required to “revise the list to include each drug which has been approved.” The obligation to revise the Orange Book “under clause (i)” (i.e., under FDC Act § 505(j)(7)(A)(i)) includes Subsection (i)(III), which FDA has said it meets through the publication of TE codes in the Orange Book.
As an aside, two Citizen Petitions (Docket Nos. FDA-2011-P-0610 and FDA-2013-P-0371) challenge FDA’s authority to assign TE ratings to 505(b)(2)-approved drug products, and, in particular, 505(b)(2) applications approved for testosterone gel, absent rulemaking under the Administrative Procedure Act (“APA”) (see our previous post here). Nevertheless, as Upsher-Smith Laboratories recently noted in comments to FDA, the Agency has continued to assign TE ratings to 505(b)(2)-approved drug products despite the petitions.
Perrigo alleges that FDA has violated the FDC Act and the APA by failing to publish a TE rating with respect to Perrigo’s NDA No. 203098. The company asks the court for both injunctive and declaratory relief. Specifically, Perrigo asks the court to enter a mandatory preliminary injunction compelling FDA to publish a TE rating for Perrigo’s NDA No. 203098 as soon as possible (and in any event no later than 14 days from the date a preliminary injunction is entered and throughout the pendency of the case), and a declaratory judgment that FDA’s failure to provide the non-discretionary statutorily-required published TE rating constitutes agency action unlawfully withheld and unreasonably delayed. In addition, Perrigo asks for a permanent injunction upon the completion of a trial on the merits.
Posted at 10:23 PM in Hatch-Waxman, Prescription Drugs and Biologics | Permalink | Comments (0)
Coming Soon: The HP&M Crossword Puzzle
(In our best Don LaFontaine voice) IN A WORLD where food and drug attorneys and regulatory professionals are all work and no play, there’s something coming to relieve the monotony and to spice up your work life.
That’s right, after a very, very long hiatus, our “Lighter Side of Food and Drug Law” is back. But as opposed to providing an entertaining story (see, e.g., here and here), this time we’re going to help exercise your brain.
Later this week, we’ll be posting an FDA-related crossword puzzle written by Jeffrey N. Gibbs and Etan J. Yeshua as part of a celebration of Hyman, Phelps & McNamara, P.C.’s 34th anniversary earlier this month. Be prepared! While it may not be The New York Times Crossword Puzzle, it’s difficult!
We’ll give FDA Law Blog readers about 48 hours to submit to us completed puzzles, then we will post the answers. A special autographed certificate will be awarded to the first person to submit a correct response, and a different certificate will be awarded for all other correct submissions. Our decision on the winner will be final, and not subject to reversal unless shown to be arbitrary and capricious. (But we’ll be the judge of that!) Stay tuned!