Source: http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2008/02/index.html
Timestamp: 2017-09-22 15:36:22
Document Index: 402737552

Matched Legal Cases: ['§ 337', '§ 110765', '§ 343', '§ 343', '§ 343', '§ 337', '§ 521', '§360', '§ 521', '§ 521', 'art 99', 'art 99', '§ 351']

FDA Law Blog: February 2008
HPM Continues Coverage of the U.S. Sentencing Commission’s Proposed Sentencing Guideline Revisions
Over the past several weeks, FDA Law Blog has closely followed issues concerning the United States Sentencing Commission’s proposed changes to the Sentencing Guidelines that are applicable to certain FDA criminal offenses. In our most recent post, we reported on a February 13, 2008 public briefing session during which representative from FDA and Hyman, Phelps & McNamara, P.C. (“HPM”) testified before the Commission on the proposal.
In the March 2008 issue of Thompson Publishing Group’s FDA Enforcement Manual, HPM’s Douglas B. Farquhar provides additional information and analysis on the proposal. In the article, titled “Heightened Chance of Prison Time for Executives?,” Mr. Farquhar discusses how the Commission’s proposal “would dramatically increase the chances that an individual being sentenced for an FDA violation would be sentenced to prison time.” According to Mr. Farquhar, FDA’s suggestion at the February 13, 2008 public briefing session that all adulterated and misbranded drugs and medical devices are worthless “would dramatically increase prison sentences imposed on individuals convicted of felony violations of federal law on the manufacture of drugs and devices.”
We will continue to update you on this important and interesting issue as we learn additional information.
Posted at 07:28 AM in Enforcement | Permalink | Comments (0) | TrackBack (0)
FDA Getting Tough on Food Claims; Agency Enters Into Consent Decree of Permanent Injunction With Two Food Companies Over Unauthorized Drug Claims
Last week, FDA announced a consent decree of permanent injunction had been entered into with two food companies - Brownwood Acres Foods, Inc. and Cherry Capital Services, Inc. (doing business as Flavonoid Services) - and their top executives, prohibiting them from making unauthorized drug and health claims about their products. The Consent Decree of Permanent Injunction, which was signed by Judge Paul Maloney on February 19th in the U.S. District Court for the Western District of Michigan, might signal FDA’s intent to police food claims more vigorously. (A copy of the Complaint for Permanent Injunction is available here.) Violations of the consent decree, which can be enforced by the court, may result in an order to stop manufacturing and distributing any product and a $1,000 per violation/per day penalty.
Although the companies make a variety of food and dietary supplement products, including juice concentrates, soft fruit gel capsules, fruit bars, dried fruits, liquid glucosamine, and salmon oil capsules, the complaint and injunction focus primarily on the companies' claims made for fruits. In the consent decree of permanent injunction, FDA alleges that the companies made unauthorized drug and health claims in violation of the Federal Food, Drug and Cosmetic Act (“FDC Act”), such as “wild blueberry compounds may inhibit cancer,” “[p]urple grape juice seems to have the same effect as red wine in reducing the risk of heart disease,” “[a] new study . . . found that drinking pomegranate juice can fight prostate cancer,” and “tart cherries . . . may help gout, arthritis, and inflammation sufferers.” The companies have previously faced enforcement for their claims about similar products. For example, in 2005, FDA sent Brownwood Acres a Warning Letter claiming that the company made unauthorized drug claims about the company’s cherry juice concentrate, blueberry juice concentrate, pomegranate concentrate, and cherry flex soft gel capsule products.
The consent decree of permanent injunction, signed by both companies and their executives, was entered into in response to the companies’ continuing to make unauthorized drug and health claims, such as “Chemicals found in Cherries may help fight diabetes.” The companies are permanently prohibited from delivering any product into interstate commerce unless and until FDA approves a drug marketing application (i.e., an NDA or ANDA), or there is an effective IND, or the product’s claims comport with an authorized health claim, or FDA issues a letter of enforcement discretion for a qualified health claim for a particular product, or until the companies remove all unauthorized drug and health claims from their websites, labels, labeling, and promotional material. The companies have also agreed to hire an independent expert to review all claims and certify that they have removed the claims objected to by FDA.
FDA’s Associate Commissioner for Regulatory Affairs, Margaret O’K. Glavin, states in the Agency’s announcement that the “FDA will not tolerate unsubstantiated health claims that may mislead consumers. The FDA will pursue necessary legal action to make sure companies and their executives manufacture and distribute safe, truthfully labeled products to consumers.” It remains to be seen whether this will be an isolated instance of FDA enforcing the FDC Act against food companies or whether this begins an increased effort by FDA to monitor the claims being made for foods.
Posted at 12:37 PM in Enforcement, Foods | Permalink | Comments (0) | TrackBack (0)
And Now for Something Completely Different: OIG Issues Noteworthy Advisory Opinions Regarding Free Trial Program and Disease State Questionnaire Kiosks
Advisory Opinion No. 08-04 (Free Trial Program)
Last week, the Office of Inspector General (“OIG”) of the Department of Health and Human Services posted an advisory opinion addressing a free drug trial program for hemophilia A patients (“Proposed Arrangement”). This was the first opinion outside of the patient assistance program context in which the OIG has evaluated the status of a free drug program under the federal healthcare program antikickback statute. As discussed below, the OIG concluded that, while the Proposed Arrangement could potentially generate prohibited remuneration under the antikickback statute, the OIG would not impose administrative sanctions on the requestor in connection with the Proposed Arrangement.
The opinion was requested by a manufacturer of a recombinant antihemophilic factor VIII product indicated for the control and prevention of hemorrhagic episodes and for surgical and short-term routine prophylaxis in patients with hemophilia A. The product is reimbursed under Medicare Part B using the Average Sales Price (“ASP”) methodology. According to the OIG, generally there are no barriers to switching between recombinant antihemophilic factor VIII products or from recombinant to plasma-derived products.
Under the Proposed Arrangement, patients would be given one complimentary trial supply of the medication, which would last from 1 to 10 weeks, depending on the patient’s weight, severity of illness, level of activity, and other factors. A limited number of enrollment forms would be provided to hemophilia treatment centers and hemophilia/oncology practices. Each patient would only be permitted to enroll in the program one time, and no patient currently on the requestor’s product would be eligible to participate in the program. The prescribing physician would identify patients who would benefit from the product, fill out enrollment forms for such patients, and write prescriptions for the product for those patients. The patient would then send the completed forms and the prescription to the administrator of the program (which is also a licensed pharmacy), which would fill the prescription and send the product directly to the patient. The physicians would never take possession of the product and would not be compensated directly or indirectly for their participation in the program. No third party payors (including federal healthcare programs such as Medicare) would be billed for product dispensed under the program. According to the opinion, the requestor certified that the program would comply with the Prescription Drug Marketing Act of 1987 (“PDMA”).
The OIG’s analysis discussed then discounted two potential antikickback concerns. First, the opinion concluded that the Proposed Arrangement did not provide any direct or indirect monetary or economic remuneration to the physicians. This is because the product would be dispensed directly to the patient, which would preclude unscrupulous physicians from reselling or billing for a sample, and, in addition, that the physicians would be required to sign a statement acknowledging that the product is complimentary and cannot be resold or billed to any third party payors.
Second, the opinion concluded that the risk of a one-time trial supply of the product inducing patients to self-refer to the product was low. This was based on four considerations:
(1) the Proposed Arrangement involved no cost to federal healthcare programs;
(2) the risk of steering patients to the product by starting them on the product was low because patients who choose to continue to use the product would still be responsible for significant cost-sharing amounts after the one-time free trial was completed, and there would be no clinical barriers to switching to another product after using the free product;
(3) the Proposed Arrangement was unlikely to result in overutilization of the product; and
(4) the Proposed Arrangement included additional safeguards, such as compliance with the PDMA, distribution of the product directly to patients, distribution of a limited number of enrollment forms each year to each physician, and the fact that physicians and the program administrator would be required to sign statements acknowledging that the product is complimentary and that it may not be resold or billed to any third party payors.
Although this opinion provides some comfort to drug manufacturers who conduct free trial voucher or sampling programs, the OIG was careful to distinguish the Proposed Arrangement from “problematic” programs that offer free goods to “seed” the marketplace, and also to caution that “we might have reached a different conclusion on different facts or with a non-PDMA compliant sampling program.”
Advisory Opinion No. 08-05 (Disease State Questionnaire Kiosks)
In addition to the Free Trial Program Advisory Opinion, late last week the OIG issued an advisory opinion regarding electronic kiosks located in physician offices that offer patients free disease state screening questionnaires (“Proposed Arrangement”). A determination on the Proposed Arrangement was requested by a manufacturer of pharmaceuticals for a number of diseases and conditions, including four “Disease States.”
Under the Proposed Arrangement, electronic kiosks that offer interactive questionnaires about the four Disease States would be placed in the waiting rooms of certain physicians. The questionnaires would consist of several questions on each of the four Disease States that the patients would be able to answer using a keyboard. Once the patient completed the questionnaire, the patient could generate a printout that would contain the screening questions and the patient’s responses, and choose to share the printout with his or her physician. Neither the interactive questionnaires nor the kiosk itself would mention any drug names. Participating physicians would neither pay nor receive payment from the manufacturer for hosting the kiosks.
The OIG analysis discusses two possible kickback scenarios: (1) a potential kickback from the manufacturer to the patient to induce them to self-refer to the manufacturer’s drugs; and (2) a potential kickback from the manufacturer to the participating physicians to induce them to prescribe the manufacturer’s drugs. The opinion first concludes that the questionnaires would not offer patients incentives for using the kiosks, such as coupons or offers of free items. Accordingly, the Proposed Arrangement would not provide anything of value and therefore would not implicate the anti-kickback statute. Second, the opinion concludes that the Proposed Arrangement would not generate prohibited remuneration under the anti-kickback statute for the participating physicians. The participating physicians would not receive payment for the space rental or utilities fees or other compensation in connection with the Proposed Arrangement. In addition, the opinion concludes that the kiosks would not enhance the attractiveness of the participating physicians’ offices to prospective patients such that they would likely select a participating physician based on whether they offered the kiosks. The opinion notes that the kiosks “amount to little more than high-tech interactive brochures.”
By Michelle L. Butler & Noelle C. Sitthikul
Farm-Raised Salmon Cases: Private Action for Violation of California State Law is Not Preempted by the FDC Act
In March 2004, California consumers filed a class action lawsuit against several grocery stores alleging that the stores violated California state law by failing to disclose the presence of the color additives astaxanthin and canthaxanthin in farmed salmon. The plaintiffs alleged that the lack of the required disclosure of these color additives caused consumers to believe that the salmon was wild salmon. (Without the color additives, the flesh of farm-raised salmon typically appears grayish.)
In the trial court, defendants successfully argued that plaintiffs’ action was preempted by Section 310 of the Federal Food, Drug, and Cosmetic Act (“FDC Act”) (21. U.S.C. § 337(a)), which states that “proceedings for the enforcement, or to restrain violations, of the [FDC Act] shall be in the name of the United States,” thus excluding private enforcement. According to the trial court, although the action was for a violation of state law, allowing plaintiffs to proceed would conflict with the congressional intent to preclude private enforcement of the FDC Act. The Court of Appeal affirmed the trial court’s decision. On February 11, 2008, however, the Supreme Court of California reversed the Court of Appeal’s decision and remanded the matter to that court for further proceedings.
Plaintiffs’ action for deceptive marketing of salmon was predicated on a California Health & Safety Code §§ 110765, 110740. This state law is effectively the same as the FDC Act provision at 21 U.S.C. § 343(a) and (k), which prohibit the misbranding of any food. Moreover, the FDC Act, at 21 U.S.C. § 343-1(a)(3), expressly authorizes states to establish their own requirements for disclosing use of color additives provided these requirements are “identical,” i.e., effectively the same, as the FDC Act requirement.
The California Supreme Court concluded that preventing plaintiffs to bring a private action for violating a state law when the FDC Act authorizes such a state law would constitute an intrusion into state sovereignty. It ruled that nothing in the text or history of 21 U.S.C. § 343-1 indicates that Congress intended to limit a state in providing legal remedies for the violation of state laws authorized by such section. Moreover, the Court concluded that the prohibition at 21 U.S.C. § 337(a) of private actions applies only to actions for a violation of the FDC Act. The Court acknowledged that allowing the present action under a state law identical to the FDC Act might result in actions that FDA would not have taken. Nevertheless, the Court noted that Congress clearly had considered such potential conflict and concluded that such a potential inconsistency was insufficient reason to preempt a private action for violation of state law.
Posted at 04:07 PM in Foods | Permalink | Comments (0) | TrackBack (0)
Supreme Court Hands Device Makers Big Victory
In an 8-to-1 decision, the U.S. Supreme Court held earlier this week that preemption principles and the 1976 Medical Device Amendments (“MDA”) bar common law claims on the basis of safety or effectiveness of devices approved by FDA under a Premarket Approval Application (“PMA”). The case, Riegel v. Medtronic, is a decisive victory for device manufacturers. In the Supreme Court’s 1996 decision in Medtronic, Inc. v. Lohr, the Court ruled that certain state tort claims involving medical devices cleared under the premarket notification (i.e., 510(k)) process are not preempted. The Riegel case provides a definitive decision preempting state tort law claims for PMA-approved devices.
The plaintiffs in the case, Charles and Donna Riegel, brought suit in the U.S. District Court for the Northern District of New York after Charles Riegel was injured in heart surgery. During the surgery, his doctor inserted a Medtronic Evergreen Balloon Catheter into his coronary artery but inflated it beyond its rated burst pressure. The catheter burst, causing Mr. Riegel to develop a blocked heart and require coronary bypass surgery. The Riegels alleged that the catheter was designed, labeled, and manufactured in a manner that violated New York common law, and that these defects caused Mr. Riegel’s injury and suffering.
Both the district court and the U.S. Court of Appeals for the Second Circuit ruled in favor of Medtronic. The Second Circuit, which joined a number of circuits that have addressed this issue, reasoned in its 2006 opinion that because devices approved through the PMA process are subject to the standards set forth in their approved applications, such devices are subject to “a requirement applicable to the device under [the FDC Act],” and that the claims for strict liability, breach of warranty, and negligent design, testing, inspection, distribution, labeling, marketing, and sale would (if successful) impose state “requirements” that differed from, or added to, the PMA-approved standards for the device.
The MDA provides federal oversight for devices and amended the FDC Act to add § 521 (21 U.S.C. §360k(a)), which states, in relevant part:
[N]o State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement –
(1) which is different from, or in addition to, any requirement applicable under this Act to the device, and
(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this Act.
In granting review in this case, the Supreme Court was asked to address the following question:
Justice Scalia, writing for the majority, stated that the Court would adhere to a view that “requirements” under the MDA include common-law causes of action for negligence. Justice Scalia explained that state tort law is a method of controlling conduct and “[s]tate tort law that requires a manufacturer’s catheters to be safer, but hence less effective, than the model the FDA has approved disrupts the federal scheme no less than state regulatory law to the same effect.” However, Justice Scalia stated that FDC Act § 521 does not prevent damages based on claims that a device manufacturer violated FDA regulations, as these “parallel” cases “add to federal requirements.”
The opinion includes interesting dictum (on page 13) with respect to the effect that FDA’s current view supporting preemption is entitled only to little deference because of the different position FDA has previously taken. Justice Scalia states in response to Justice Ginsburg’s dissent that:
In the case before us, the FDA has supported the position taken by our opinion with regard to the meaning of the statute. We have found it unnecessary to rely upon that agency view because we think the statute itself speaks clearly to the point at issue. If, however, we had found the statute ambiguous and had accorded the agency’s current position deference, the dissent is correct . . . that - inasmuch as mere Skidmore deference would seemingly be at issue - the degree of deference might be reduced by the fact that the agency’s earlier position was different. . . . But of course the agency’s earlier position . . . is even more compromised, indeed deprived of all claim to deference, by the fact that it is no longer the agency’s position.
Justice Ginsburg, the lone voice of dissent, argued that “Congress. . .did not intend [FDC Act § 521] to effect a radical curtailment of state common-law suits seeking compensation for injuries caused by defectively designed or labeled medical devices.” Justice Ginsberg admonished the majority’s decision as contrary to the “MDA’s central purpose: to protect consumer safety.”
Sen. Edward Kennedy (D-MA), who sponsored the MDA, spoke out against the decision, stating “Congress never intended that FDA approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices.” Rep. Henry Waxman (D-CA) also expressed disappointment with the decision, vowing that Congress will “pass legislation as quickly as possible to fix this nonsensical situation.”
Additional information on this case, including briefs and analysis, is available from SCOTUSBlog.
Posted at 11:15 AM in Medical Devices | Permalink | Comments (0) | TrackBack (0)
Posted at 07:03 AM in Hatch-Waxman | Permalink | Comments (0) | TrackBack (0)
FDA Ignores Rep. Waxman and Issues Draft Guidance on Good Reprint Practices
In December 2007, we reported on what was a then yet-to-be-released FDA draft guidance on Good Reprint Practices (“GRPs”) and Rep. Henry Waxman’s (D-CA) November 30, 2007 letter to FDA strongly urging the Agency to refrain from disseminating the draft guidance and requesting certain information related to the draft guidance. On December 21, 2007, FDA responded to Rep. Waxman by providing some of the requested information and refusing to provide other information reflecting ongoing Agency deliberations. Rep. Waxman penned another letter to FDA in January 2008 criticizing the Agency for not providing much of the requested information. For now, it appears that FDA is moving forward with the draft guidance. Last Friday, FDA announced the availability of the draft GRP guidance. FDA will publish a notice in the Federal Register later this week formally announcing the availability of the GRP draft guidance. Once finalized, the draft GRP guidance will effectively “replace” FDA’s regulations at 21 C.F.R. Part 99, which expired in September 2006 with the sunsetting of Section 401 of the 1997 FDA Modernization Act. (We note that many companies did not utilize Part 99 in disseminating reprints, so there wasn't much to replace.)
As we reported in December, and contrary to the treatment of the subject in the mainstream media, the general principles articulated in the draft guidance are consistent with FDA’s prior approach and are not a radical departure from Agency practice, or, for the most part, current industry practice. In fact, although Rep. Waxman is concerned that the guidance would “open the door to abusive marketing practices that will jeopardize safety,” the draft guidance provides more restrictive requirements on how the reprint must be disseminated and clarifies the types of documents that FDA considers acceptable for dissemination. The guidance states that letters to the editors, abstracts, Phase 1 study reports, and reference publications that contain little or no substantive discussion of the relevant investigation or data are not consistent with GRPs. (As we reported in December, there has been debate among practitioners as to whether these types of documents were appropriate to disseminate.) In addition, some new requirements include: distributed scientific or medical information should be accompanied by a comprehensive bibliography of publications discussing adequate and well-controlled clinical studies, be distributed separately from information that is promotional in nature, and be in the form of an unabridged reprint, copy of an article, or reference publication that is free of highlighting, markings, and manufacturer summaries.
Although industry critics are concerned about potential abuse by manufacturers, industry proponents point to FDA’s own statement that the “public health can be served when health care professionals receive truthful and non-misleading scientific and medical information” as support for their position that reprints are beneficial. In fact, while many companies’ marketing practices will be unaffected by the draft GRP guidance, more aggressive companies may find their marketing practices reigned in. As Hyman, Phelps & McNamara, P.C.’s Jeffrey Wasserstein (and FDA Law Blog co-author) stated in the Saturday edition of The Wall Street Journal, “There’s tremendous variation in company practices . . . . [The draft GRP guidelines will] probably restrict the more aggressive companies.”
Considering the early start on the debate surrounding the draft GRP guidance, we anticipate escalating debate in the comings months. As we noted in December 2007, there is a constitutional dimension to this issue, since the Washington Legal Foundation ("WLF") line of cases made clear that dissemination of reprints was constitutionally protected free speech. It remains an open question as to whether industry or free speech advocates, such as WLF, will choose to challenge FDA's guidance on First Amendment grounds, or whether industry will learn to live with this as a reasonable compromise.
Posted at 07:04 AM in Drug Development, Medical Devices | Permalink | Comments (0) | TrackBack (0)
Merck Resolves Claims of Fraudulent Price Reporting and Kickbacks Alleged in Coordinated Federal-State Investigation
On February 7, 2008, the U.S. Department of Justice announced that Merck & Company, Inc. (“Merck”) agreed to pay more than $650 million to settle allegations that the company failed to pay proper rebates to Medicaid and paid illegal remuneration to health care providers to induce prescriptions for the company’s products. The allegations arose out of lawsuits brought by a former Merck employee and a Louisiana physician under the Federal False Claims Act ("FCA") and state false claims laws. The FCA allows for private individuals to file a qui tam or whistleblower suit on behalf of the government. Many state false claims laws have similar whistleblower provisions. As part of the settlement agreement, one of the whistleblowers will receive approximately $68 million. The other whistleblower will receive $24 million of the Federal government’s settlement and an undisclosed share of the states’ proceeds.
In the first lawsuit, with respect to which Merck agreed to pay $399 million plus interest, H. Dean Steinke, a former Merck district sales manager, alleged in civil actions filed in Pennsylvania and Nevada that Merck instituted programs throughout the country designed to induce physicians to prescribe the company’s products over those of competitors in violation of federal and state anti-kickback laws and “best price” requirements under the Medicaid Rebate Statute. Merck’s alleged fraudulent and illegal practices included paying physicians for unnecessary preceptorships and tutorials for Meck sales representatives; paying physicians to participate in bogus “clinical experience” studies and focus groups; paying speaker fees; offering free gifts to physicians who attended promotional programs; and offering unrestricted grants for computer systems and other benefits to physicians who supported Merck products.
Merck also allegedly offered deep discounts to hospitals for ZOCOR and VIOXX but only if they met certain performance levels by using these drugs over competing products. Merck excluded these discounts from its determination of Medicaid Rebate best price under a statutory exception for “nominal prices” – i.e, prices that are less than 10 percent of the company’s weighted average price to wholesalers and retailers – thereby avoiding substantial Medicaid Rebates. However, the government contended that these pricing schemes did not qualify for the nominal price exclusion, presumably because they were linked to market share performance.
In a separate suit filed by Louisiana physician William St. John LaCorte, and with respect to which Merck agreed to pay $250 million plus interest, Merck was similarly alleged to have provided deep discounts on its PEPCID products to hospitals and other healthcare institutions in return for commitments to switch patients from competing products. As with ZOCOR and VIOXX, Merck allegedly failed to include the PEPCID discounts in Medicaid Rebate best price, and the government considered the nominal price exception inapplicable.
As part of the resolution of the cases, Merck and the Office of Inspector General (“OIG”) of the Department of Health and Human Services entered into a Corporate Integrity Agreement for five years. Among other things, the Corporate Integrity Agreement requires Merck and an Independent Review Organization to conduct annual reviews of the company’s Medicaid Rebate policies and procedures, and requires an IRO to conduct reviews of the company’s promotion and product services activities, such as promotional programs, speaker programs, consultancies, and grants.
Posted at 07:28 AM in Enforcement | Permalink | Comments (0)
Rep. Eshoo Proposes Draft Biogenerics Bill
The debate over biogenerics legislation has intensified with the anticipated introduction of legislation to create a “generic biologics” approval pathway and that would grant innovators (i.e., reference product sponsors) and certain generic sponsors market exclusivity. The draft legislation obtained by FDA Law Blog is titled the “Pathway for Biosimilars Act,” and will reportedly be introduced by Representative Anna Eshoo (D-CA) in the near future.
The draft Eshoo bill would amend PHS Act § 351 to add subsection (k) (“Licensure of Biological Products as Biosimilar”) to permit the submission of an application for licensure of a biogeneric that includes, among other things, information demonstrating that the biogeneric is biosimilar to a reference product based on analytical studies, animal studies, and a clinical study or studies (such as an immunogenicity assessment and pharmacokinetics or pharmacodynamics) sufficient to demonstrate the safety and efficacy of the biosimilar product. Analytical and animal studies may be waived by the Department of Health and Human Services Secretary (“Secretary”) if such studies are determined to be unnecessary. The Secretary may waive immunogenicity studies if there is a final guidance document “advising that it is feasible in the current state of scientific knowledge to make determinations on immunogenicity with respect to products in the product class to which the biological product belongs,” and that explains “the data that will be required to support such a determination.”
Importantly, the Secretary may not accept a biogeneric application until a proceeding has been initiated for the issuance of a guidance document for the product class in which the biogeneric falls, and the Secretary may not approve a biogeneric application until that proceeding is completed. Product class-specific guidance documents must include criteria for determining biosimilarity, interchangeability, and immunogenicity (if available). In addition, companies may not submit a biogeneric application until the later of the commencement of guidance document proceedings (product class-specific) or the date that is 4 years after initial licensing of the reference product (not including the date of a supplement approval or of a subsequent application for a new indication, route of administration, dosage form, or strength of the previously licensed reference product). A person may petition the Secretary to commence guidance document proceedings for a reference product licensed more than 7 years prior to the date of enactment of the “Pathway for Biosimilars Act.” The sponsor of the first biogeneric determined to be interchangeable may receive a 24-month period of market exclusivity from the later of either the first commercial marketing of its biogeneric, or, “with respect to a product marketed before the date the product is determined to be interchangeable, the date that the product is determined to be interchangeable.”
The quid pro quo for innovator companies is a period of 12-year exclusivity after initial licensure that may be increased to 14.5 years. Specifically, if during the 8-year period following licensure of the reference product, the Secretary approves a supplement for a new indication that would be a “significant improvement” compared to marketed products, then a biogeneric application may not be made effective until 14 years after initial licensure of the reference product. The 12-year or 14-year exclusivity periods may be extended by 6 months if “at any time following licensure of the reference product, the holder of the approved application for the reference product files a supplemental application to support use in pediatric age groups (including neonates) containing reports of new clinical investigations (other than bioavailability studies) essential to the approval of the application that were conducted or sponsored by the holder.”
In addition, reference product sponsors, as well as interested third parties (such as universities), that own a patent on the reference product may sue a biogeneric applicant for patent infringement. Under certain circumstances, such litigation could delay the approval of the biogeneric product. The draft bill also places certain limitations on the availability of declaratory judgment actions for biogeneric applicants, and amends the user fee law to require biogeneric applicants to pay the same user fees required to be paid by reference product sponsors.
In other biogenerics news, FDA Law Blog learned that the regulatory authorities north of the border in Canada recently released a draft guidance document outlining the regulatory review process that Health Canada will use for a biologic that is similar to an approved innovator biologic. In Canada these product are referred to as “Subsequent Entry Biologics.”
Posted at 10:26 AM in Drug Development, Hatch-Waxman | Permalink | Comments (0) | TrackBack (0)
Posted at 05:02 PM in Drug Development | Permalink | Comments (0) | TrackBack (0)