Source: http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2009/06/index.html
Timestamp: 2014-10-30 15:54:59
Document Index: 711409011

Matched Legal Cases: ['§ 505', '§ 505', '§ 505', '§ 505', '§ 505', '§ 505', '§ 505', '§ 505', '§ 505', '§ 355', '§ 505', '§ 505', '§ 505', '§ 505', '§ 417', '§ 417', '§ 417']

FDA Law Blog: June 2009
Implementation of the Family Smoking Prevention and Tobacco Control Act: FDA Wants to Hear From You
By David B. Clissold & Ricardo Carvajal – In an unusually open-ended request, FDA is asking “all interested parties to provide information and share views” on FDA’s implementation of the Family Smoking Prevention and Tobacco Control Act ("Tobacco Act"), which was signed into law on June 22, 2009. FDA seeks “comments that will inform strategies to protect the public health” as it implements the new legislation, and is “particularly interested in comments on the approaches and actions the agency should consider initially to increase the likelihood of reducing the incidence and prevalence of tobacco product use and protecting the public health.” Notably, in taking certain actions under the Tobacco Act, FDA is required to consider the effects of its action on the incidence of tobacco product use and whether its action is appropriate for the protection of public health. The notice asks that comments be organized into the following categories: Federal, State, and local government collaboration; New product submission and approval; Product ingredient disclosure; Prevention; Tobacco use by specific groups including minors, women, and racial and ethnic minority populations; Tobacco addiction; Smoking cessation; Data collection; Products with reduced harm/risk claims; Enforcement; Research and testing; Advertising and marketing of tobacco products; Label statements and warnings (including graphic warnings); Tobacco product standards (including flavors, ingredients, etc.); Sale and distribution of tobacco products; Manufacturing restrictions and facilities controls; and Other. Information that FDA receives in response to its request could well help the agency implement the Tobacco Act within the aggressive timeframes that the Act imposes. However, given the open-ended nature of the request, and the fact that FDA’s attempted regulation of tobacco in the mid-90’s netted over a half-million comments, FDA had better be ready for a deluge.
Posted at 01:23 PM in Miscellaneous | Permalink
FDA Firms Up Implementation Date for the Reportable Food Registry
By Ricardo Carvajal – FDA has announced public workshops on the Reportable Food Registry intended to “explain the purpose of the Registry, how it will work, and the responsibilities of persons required to submit a report regarding instances of reportable food to FDA through the Reportable Food electronic portal.” The public workshops will also address the role of public health officials in submitting instances of reportable food to the Registry. Previously, FDA issued and requested comment on a draft guidance titled “Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007” (see our prior posting here). At that time, the agency indicated that the Registry would be implemented on September 8, 2009. This latest announcement of the public workshops suggests that further delays in implementation of the Registry are unlikely, and that FDA intends to meet the September 8 implementation date. Have you incorporated the Registry requirements into your recall SOP’s and training program?
Posted at 02:11 PM in Foods | Permalink
Teva Sues FDA Over Generic COZAAR and HYZAAR 180-Day Exclusivity Forfeiture and Patent Delisting Rule
By Kurt R. Karst – Teva Pharmaceuticals USA, Inc. (“Teva”) recently filed a Complaint and a Motion for Preliminary Injunctive Relief (and a memorandum supporting the company’s motion) in the U.S. District Court for the District of Columbia against FDA concerning 180-day exclusivity forfeiture for generic versions of Merck & Co., Inc.’s (“Merck’s”) blockbuster angiotensin II receptor antagonist drugs COZAAR (losartan potassium) Tablets and HYZAAR (hydrochlorothiazide; losartan potassium) Tablets. Teva’s lawsuit is the latest challenge to FDA’s interpretation of the “failure to market” 180-day exclusivity forfeiture provisions at FDC Act § 505(j)(5)(D)(i)(I), and in particular with respect to FDA’s interpretation of the patent information withdrawal provision at FDC Act § 505(j)(5)(D)(i)(I)(bb)(CC). The 180-day exclusivity forfeiture provisions were added to the FDC Act in December 2003 by the Medicare Modernization Act (“MMA”).
Under the FDC Act, an ANDA applicant who is a “first applicant” (i.e., “an applicant that, on the first day on which a substantially complete [ANDA] containing a [Paragraph IV certification] is submitted for approval of a drug, submits a substantially complete [ANDA] that contains and lawfully maintains a [Paragraph IV certification]”) is eligible for 180-day exclusivity, but forfeits such exclusivity if there is a “failure to market” under FDC Act § 505(j)(5)(D)(i)(I). Specifically, FDC Act § 505(j)(5)(D)(i)(I) states that a first applicant forfeits 180-day exclusivity if it fails to market the drug by the later of two dates: (aa) the earlier of the date that is – (AA) 75 days after the date on which the approval of the application of the first applicant is made effective under subparagraph (B)(iii); or (BB) 30 months after the date of submission of the application of the first applicant; or
(bb) . . . the date that is 75 days after the date as of which, as to each of the patents with respect to which the first applicant submitted and lawfully maintained a certification qualifying the first applicant for the 180-day exclusivity period under subparagraph (B)(iv), at least 1 of the following has occurred: (AA) In an infringement action brought against that applicant with respect to the patent or in a declaratory judgment action brought by that applicant with respect to the patent, a court enters a final decision from which no appeal (other than a petition to the Supreme Court for a writ of certiorari) has been or can be taken that the patent is invalid or not infringed. (BB) In an infringement action or a declaratory judgment action described in subitem (AA), a court signs a settlement order or consent decree that enters a final judgment that includes a finding that the patent is invalid or not infringed. (CC) The patent information submitted under [FDC Act § 505(b) or (c)] is withdrawn by the holder of the application approved under [FDC Act § 505(b)]. [(Emphasis added)]
In FDA’s May 2008 Letter Decision concerning 180-day exclusivity for generic PRECOSE (acarbose) Tablets, the Agency ruled that a request to withdraw patent information from the Orange Book is a forfeiture event under FDC Act § 505(j)(5)(D)(i)(I)(bb)(CC). (See our May 11, 2008 post here.) In reaching this conclusion, FDA determined that the U.S. Court of Appeals for the District of Columbia Circuit’s 2006 decision in Ranbaxy Labs. Ltd. v. Leavitt holding that FDA may not condition the delisting of a patent on the existence of patent litigation and deprive an ANDA applicant eligible for 180-day exclusivity of such exclusivity does not apply to the version of the FDC Act amended by the MMA. FDA’s PRECOSE Letter Decision states:
[T]he Ranbaxy court noted that the decisions rendered by the FDA and the district court had been made pursuant to the Act “as it stood before the MMA and, because the MMA was not made retroactive . . . this decision is also geared to the Act pre-MMA” (469 F.3d at 122). Therefore, the court did not purport to render a decision on patent delisting and exclusivity under the MMA. The effect of patent delisting on eligibility for 180-day exclusivity is expressly addressed by the plain language of section 505(j)(5)(D)(i)(I) of the Act. . . . FDA reads the plain language of 505(j)(5)(D)(i)(I)(bb)(CC) to apply whenever a patent is withdrawn (or requested to be “delisted”) by the NDA holder. FDA’s Letter Decision was challenged in the U.S. District Court for the District of Columbia; however, the challenge was abandoned after the court denied a generic applicant’s motion for a temporary restraining order. In October 2008, FDA once again applied its interpretation of FDC Act § 505(j)(5)(D)(i)(I)(bb)(CC) when the Agency issued a Letter Decision ruling that Hi-Tech Pharmacal Co., Inc. (“Hi-Tech”) forfeited 180-day exclusivity for a generic version of Merck’s COSOPT (dorzolamide hydrochloride; timolol maleate) after the information on two exclusivity-qualifying Orange Book-listed patents covering the drug had been withdrawn by Merck. (See our October 28, 2008 post here.) FDA issued its Letter Decision after the U.S. District Court for the District of Columbia decided not to grant Hi-Tech’s preliminary injunction motion seeking to prevent FDA from granting final ANDA approval to any subsequent ANDA applicant during Hi-Tech’s period of 180-day exclusivity and to obtain a prompt exclusivity decision from FDA to allow Hi-Tech to seek judicial relief in case of an adverse FDA decision. Hi-Tech challened FDA’s Letter Decision in the U.S. District Court for the District of Columbia, but was ultimately unsuccessful in its lawsuit. (Teva submitted an amicus brief in that case.) According to Teva’s Complaint, the company believes it is a first applicant with respect to both COZAAR and HYZAAR based on ANDA submissions in 2003 and 2004. There are three patents listed in the Orange Book for both drug products. Teva reportedly submitted a Paragraph III certification with respect to two of the patents, which expire in February and April 2010, and a Paragraph IV certification with respect to U.S. Patent No. 5,608,075 (“the ‘075 patent”), which expires in September 2014. Subsequent to Teva’s Paragraph IV certification, Merck reportedly requested that FDA withdraw (or “delist”) the ‘075 patent information from the Orange Book for both COZAAR and HYZAAR. Thus, according to Teva:
forfeiture events have already occurred under both prongs of the failure-to-market trigger. As of August 12, 2006, thirty months had passed from the date Teva submitted its ANDA for generic Cozaar. And as of January 16, 2007, thirty months had passed from the date Teva submitted its ANDA for generic Hyzaar. these dates serve as the applicable dates in the (aa) subsection of the failure-to-market provision . . . . And with respect to the (bb) subsection, well over 75 days now have passed from the date that Merck voluntarily asked FDA to delist the ‘075 patent from the Orange Book’s patent listings for Cozaar and Hyzaar.
But Teva argues that it should not forfeit 180-day exclusivity because FDA’s interpretation of FDC Act § 505(j)(5)(D)(i)(I)(bb)(CC) (which Teva terms as the “Delisting Rule” in its court papers) is unlawful. Teva states that:
The Agency’s assertion that the delisting trigger renders Ranbaxy irrelevant because the trigger now “expressly addresses” the “effect of patent delisting” is a classic non-sequitur. While the delisting trigger unquestionably addresses “the effect” of patent delistings after they occur, it says nothing about when patent delistings are permissible – and thus can occur – in the first instance. Other amendments made by the MMA supply the answer to that question, by creating a new mechanism for delisting: a cause of action that for the first time allows patent-challenging generic applicants to seek a court order compelling the brand manufacturer to delist a challenged patent against its will. See 21 U.S.C. § 355(j)(5)(C)(ii)(I).
Read together, as statutory provisions must be, it thus is clear that these twinAmendments – the delisting mechanism, on one hand, and the delisting trigger, on the other – were not remotely intended to open the proverbial floodgates to manipulative, exclusivity-divesting patent delistings by brand manufacturers, and thus sub silentio to abrogate the longstanding prohibition against such delistings that Ranbaxy recognized. To the contrary, these interlinked provisions merely provide that when a first applicant secures a court-ordered patent delisting that clears the last remaining hurdle to generic competition, it cannot indefinitely delay generic competition by refusing to sell its product for more than 75 days after the court-ordered delisting. Beyond that, however, the delisting trigger does not remotely authorize manipulative patent delistings that take place apart from, and wholly outside the confines of, the statute’s new delisting mechanism. FDA has no answer to this simple point, and it is dispositive. [(Emphasis in original)]
Furthermore, Teva states that FDA’s policy – as expressed in the Hi-Tech case – of not providing early exclusivity decisions, but rather issuing 180-day exclusivity decisions simultaneous with taking action on ANDA approvals, “has shielded the Delisting Rule from challenge in the courts” and “thwarts effective judicial review of that rule.” Thus, Teva argues that “[b]ecause FDA’s Delisting Rule is arbitrary, capricious and contrary to law, and because any delay will deprive both Teva of its right to meaningful judicial relief and the public of its right to access generic losartan potassium products, the Delisting Rule immediately must be invalidated.”
Although originally assigned to Judge Gladys Kessler, the Teva case has been reassigned to Judge Rosemary M. Collyer. FDA’s response, originally due on June 26th, will likely be due on July 1st once Judge Collyer rules on an unopposed motion for extension of time for FDA to respond to Teva’s preliminary injunction. We will certainly be watching this case closely and will update FDA Law Blog readers on important developments. Posted at 01:58 PM in Hatch-Waxman | Permalink
By Kurt R. Karst –	Section 11 of the Best Pharmaceuticals for Children Act (“BPCA”) of 2002 amended the FDC Act to add a new provision, which was reauthorized under the FDA Amendments Act of 2007 and is located at FDC Act § 505A(o), to require the prompt approval of ANDAs when pediatric information protected by patent or exclusivity is added to the labeling of a Reference Listed Drug. Specifically, FDC Act § 505A(o) states:
FDC Act § 505A(o) has been applied in several instances since the enactment of the BPCA in 2002. For example, FDA has approved generic versions of GLUCOPHAGE (metformin HCl), AGRYLIN (anagrelide HCl) (here and here), and PRILOSEC (omeprazole) with labeling that omits certain protected pediatric information, but that also includes certain essential pediatric safety information, regardless of pediatric exclusivity. Moreover, in 2003, FDA responded to a citizen petition in which the Agency stated that it would apply Section 11 of the BPCA with respect to generic versions of ALPHAGAN (brimonidine), and issued a Manual of Policies and Procedures discussing, among other things, the review of generic drug labeling pursuant to Section 11 of the BPCA. Given the interest our previous post and scorecard on labeling carve-out issues generated, we thought it would be worthwhile to update the scorecard with a more complete list of petitions and FDA responses and to add a new section on BPCA Section 11 (FDC Act § 505A(o)) petitions (for which there will likely be only a few petitions given the express language in the statute).
FDA Response, Docket No. 2006P-0410 (Mar. 13, 2008) – ETHYOL (amifostine) FDA Response, Docket No. FDA-2007-P-0169 (Apr. 25, 2008) – MARINOL (dronabinol)
FDA Response, Docket No. 2003P-0518 (Sept. 20, 2004) - RAPAMUNE (sirolimus) Pending Labeling Carve-Out Citizen Petitions
FDA Docket Nos. FDA-2004-P-0426 and FDA-2003-P-0081; FDA Letter – SKELAXIN (metaxalone) FDA Docket No. 2007P-0322 – ACTOS (pioglitazone)
FDA Response, Docket No. 2002P-0469 – ALPHAGAN (brimonidine) Posted at 07:06 PM in Hatch-Waxman | Permalink
The United States Files Criminal Charges Against Orthopedic Device Manufacturers and Four Executives
By Carmelina G. Allis – We previously reported that the State of New Jersey had entered into an agreement with Synthes, Inc. to settle allegations that the company failed to disclose financial conflicts of interest among doctors who conducted clinical testing on its products. Now, Synthes has been charged by the United States government for allegedly violating several provisions of Titles 18 and 21 of the United States Code. The 58-page indictment includes conspiracy and false statement counts under Title 18, in addition to violations of the Federal Food, Drug, and Cosmetic Act by allegedly introducing into interstate commerce adulterated and misbranded devices. The indictment also charges Norian Corporation, a wholly owned Synthes subsidiary, Michael D. Huggins (President of Synthes North America), Thomas B. Higgins (Senior Vice President of Global Strategy of Synthes), Richard E. Bohner (Vice President of Operations), and John J. Walsh (Director of Regulatory and Clinical Affairs, Spine Division).
In brief, the defendants allegedly conducted clinical trials of a significant risk device without an approved Investigational Device Exemption ("IDE"), introduced into interstate commerce a device without FDA clearance or approval, and made false statements to government officials. The indictment alleges that Synthes, an orthopedic device manufacturer, purchased Norian Corporation in 1999, the manufacturer of Norian SRS, a calcium phosphate bone cement. Some time in 2000, several of Synthes’s employees allegedly conducted interviews of several surgeons with the purpose of creating a market for a version of Norian SRS with radiopaque barium sulfate for use in vertebroplasty and kyphoplasty surgeries to treat vertebral compression fractures ("VCFs"). This product was eventually marketed by defendants as “Norian XR.”
The indictment alleges that Norian SRS mixed with barium sulfate and Norian XR cannot be used on high-pressure vertebroplasty procedures, such as VCFs, because it is too thick and liquid and suspended particle components can separate/dewater. Such leakage into the venous system can allegedly cause pulmonary embolism and death. According to the indictment, prominent orthopedic surgeons had warned defendants that the Norian product in its pre-hardened state may interact with blood and cause serious adverse events, and that pre-clinical tests were recommended prior to using the product in humans. In 2002, defendants allegedly learned the results of in-vitro studies conducted on human blood that allegedly demonstrated that the Norian calcium component interacts with blood, providing both a surface on which clot could form and a chemical stimulus to clot formation.
In 2001, defendants obtained FDA clearance to market Norian SRS as a general bone void filler for bony voids not intrinsic to the stability of the bony structure. The cleared labeling warned that the Norian SRS was not to be mixed with any other substance. According to the indictment, defendants engaged in the “test market” of the Norian SRS by directing employees to create a recipe for mixing Norian SRS with barium sulfate (known as “black-table mixing”); distributing the recipe for black-table mixing of Norian SRS to spine surgeons to treat VCFs; training spine surgeons to treat VCFs with the mixed Norian SRS; directing employees to attend such training sessions; and gathering safety and effectiveness data from spine surgeons using the mixed product to treat VCFs.
FDA later cleared the Norian XR as a general bone void filler in 2002, and specifically required that the labeling include a warning indicating that the device was not intended for the treatment of VCFs. Defendants allegedly also engaged in a “test market” operation of the Norian XR for the off-label use to treat VCFs. Between 2003 and 2004, three patients died on the operating table after suffering hypotensive episodes while using Norian XR to treat VCFs. The surgeons could not rule out Norian XR as a cause of the deaths. In all cases, Synthes Spine sales representatives were present in the operating room during the surgeries. In 2004, FDA conducted an inspection of the Norian facility and cited the company for not having submitted an IDE prior to initiating the Norian XR “test market” and for shipping Norian XR in interstate commerce for off-label VCF uses.
The indictment alleges that the defendants conspired to approve, organize, and sponsor: (1) an illegal vertebroplasty clinical trial through a “test market” of the device; (2) surgeon forums at which spine surgeons were taught how to use Norian XR to treat VCFs; and (3) the sale of Norian XR to spine surgeons for the intended use of treating VCFs to gather an analyze safety and effectiveness information on the use of the device to treat VCFs. The indictment also alleges that defendants conspired to conceal from spine surgeons and Synthes’s own Spine sales team information that Norian SRS and/or Norian XR could accelerate blood clot formation if it escaped from bone into the venous circulation, and also failed to disclose to surgeons and sales personnel that Norian XR was contraindicated in its labeling for the treatment of VCFs. The indictment alleges that the defendants sent “dear doctor” letters to spine surgeons admitting that the use of Norian XR to treat VCFs was off-label, but that the letter omitted the thrombogenicity potential of the product and the three patients’ deaths. The indictment also alleges MDR violations and making false and misleading statements to FDA investigators regarding the off-label use of the device.
According to the press release by the United States Attorney, Norian faces a fine of $26 million and Synthes faces a fine of $8.8 million, among probation and special assessments. Each of the individual defendants faces a maximum sentence of one year in prison, a fine of $100,000, full restitution, and one year of supervised release.
All of the alleged violations occurred between 2003 and 2004.
Posted at 04:41 AM in Enforcement, Medical Devices | Permalink
JP Ellison – The U.S. Attorney's Office for the Western District of Missouri announced three guilty pleas to misdemeanor violations of the FDC Act in connection with the "nationwide recall of pet food and the death and serious illness of countless pets across the United States in 2007." Sally and Stephen Miller – husband and wife and the owners of ChemNutra Inc. – and ChemNutra itself each pled guilty to 2 misdemeanor counts "one count of selling adulterated food and one count of selling misbranded food." Given the defendants' alleged role in this high profile case and the public outrage associated with the widespread death of pets, it seems a pretty safe bet that the U.S. Attorney's Office concluded that there was not evidence against these defendants of intent to defraud and mislead the public or the FDA, which would have made these offenses felonies. Assuming that there was no such evidence in this case, it is a reminder to all "responsible corporate agents" that the FDC Act imposes strict liability criminal penalties under U.S. v. Park, 421 U.S. 658 (1975). Posted at 09:19 AM in Enforcement, Foods | Permalink
Reportable Food Registry Will be Operational in September 2009
By Riëtte van Laack – The FDA Amendments Act (“FDAAA”) amended the Food, Drug, and Cosmetic Act (“FDC Act”) to create section 417, which directs FDA to establish a Reportable Food Registry (“Registry”). The purpose of the Registry is to provide a “reliable mechanism to track patterns of adulteration in food [which] would support efforts by [FDA] to target limited inspections resources to protect the public health.” Section 417 includes requirements for a responsible party (defined as “owner, operator or agent in charge of a . . . facility engaged in manufacturing, processing, packaging or holding foor for consumption in the United States”) to submit “instances of reportable food” to FDA. In addition, the responsible party must notify immediate previous sources and subsequent recipients of the reportable food. A “reportable food” is a food “for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals.”
Pursuant to FDAAA, FDA was to establish the Registry by September 27, 2008. On May 27, 2008, FDA issued a Federal Register notice stating that the Agency would not meet this deadline, but that the Agency expected to have the Registry ready for operation in Spring 2009. On June 11, 2009, FDA issued a second Federal Register notice stating that the Registry is again delayed and will be operational on September 8, 2009. In the same notice, FDA announced the availability of a draft guidance document addressing questions regarding the Reportable Food Registry. The draft guidance clarifies the duties of a responsible party under FDC Act § 417. Most of the information in the draft guidance could be obtained by a careful reading of section 417 and other sections which are referenced in section 417. However, the draft guidance also clarifies some of the less obvious issues such as the notification duties when more than one responsible party is involved (see question 22); the notification duties when there are multiple immediate previous sources or subsequent recipients (see question 24); and acceptable means of notification (see question 26).
Although not required by law, FDA encourages “responsible parties to contact their FDA district office and state or local public health or regulatory officials as soon as possible if they determine that [a food] is a reportable food.”
The draft guidance also clarifies that FDC Act § 417 does not affect FDA’s position (FDA Compliance Policy Guide 7126.20) regarding salvage of adulterated human or animal food by diverting that food to an acceptable animal food use. The guidance does not appear to address questions submitted to FDA in response to the Agency’s May 2008 Federal Register notice, such as how FDA will address issues regarding coordination between FDA and the U.S. Department of Agriculture and whether anyone can report to the internet portal required by FDC Act § 417. To ensure that FDA considers comments to the draft guidance, the Agency asks that comments be submitted by July 27, 2009.
Posted at 09:17 AM in Foods | Permalink
As we previously reported, although FDA initially determined that one PEP was an orphan drug eligible for seven years of orphan drug exclusivity, that designation was revoked after the Agency determined that the U.S. prevalence of EPI was greater than the statutory 200,000 person prevalence established under the Orphan Drug Act when orphan drug designation was requested. FDA has since stated that “[p]eople of all ages with EPI due to cystic fibrosis, chronic pancreatitis, and other conditions take these products. The estimated number of patients in the United States with EPI is over 200,000.” Although FDA stated in the preamble to the Agency’s proposed 1989 regulations implementing the Hatch-Waxman Amendments that “FDA will consider whether a drug contains a previously approved active moiety on a case-by-case basis,” the usual situation in which a drug product is eligible for five-year exclusivity is when it contains only known previously unapproved (that is “new”) active moieties. FDA has, however, found a drug to be an NCE – post-NDA approval – despite the presence of its active moiety in a previously approved drug. For example, in July 1993, FDA granted five-year exclusivity to CONDYLOX (podofilox) Topical Solution (NDA No. 19-795), a refined, single-ingredient version of a product already approved in an NDA as a mixture, after the Agency determined that the record of previous NDA approvals did not demonstrate that podofilox was an active ingredient in the mixtures FDA approved. Specifically, FDA stated in response to a citizen petition (FDA Docket No. 1992P-0051) that although “several previously approved NDA’s contained podophyllum or podophyllum resin . . . these previously approved NDA’s did not characterize podofilox as an active ingredient. Consequently, your request for five-year exclusivity for podofilox is granted . . . .” Thus, in rendering its decision that CONDYLOX was entitled to five-year NCE exclusivity, FDA relied on the fact that previously approved NDAs containing podofilox failed to characterize podofilox as an active ingredient. More recently, FDA presumed NCE status and granted NCE exclusivity for a drug about which the Agency has insufficient information to know whether or not it contains a previously approved active moiety. FDA stated this “presumption in favor of NCE status” policy in the context of the Agency’s approval of various non-recombinant hyaluronidase drug products. In the case of hyaluronidase, uncertainty arose from the fact that such drug products are complex proteins that are not fully characterized. FDA stated in an October 2005 citizen petition response (FDA Docket No. 2005P-0134) concerning hyaluronidase exclusivity that:
Importantly, with respect to pancrelipase, FDA stated in the Agency’s exclusivity determination contained in the summary basis of approval package for one hyaluronidase drug product – HYDASE (hyaluronidase) Injection (see pages 15-21) – that “[i]n at least two instances, however, the Agency did not grant NCE status in a circumstance where it might have been presumed . . . (menotropin/urofollitropin and pancrelipase)” (emphasis added). It seems reasonable to conclude that FDA’s delayed exclusivity determination for CREON is the result of debate within the Agency over the further application of FDA’s presumption in favor of NCE status, and how FDA can meet the stated “need for a range of products to remain available for patient use” if the Agency ultimately decides to grant three-year new clinical investigation exclusivity instead of five-year NCE exclusivity. It is unclear whether FDA will soon make a decision, but we will be closely watching this case. Posted at 01:31 PM in Hatch-Waxman | Permalink