By Ricardo Carvajal –

The massive spending bill to which food safety legislation was attached (and that also includes provisions on rare and neglected diseases) – the Fiscal Year 2011 Omnibus Appropriations Act – has been pronounced dead.  Although Congress may yet find another vehicle for food safety legislation, that prospect seems increasingly tenuous, and opponents are cautiously predicting victory.  The fate of the legislation in the next Congress is unpredictable.  

As we have previously noted, FDA isn’t sitting on its haunches pending the passage of food safety legislation that would give the agency clear authority to take certain measures it views as essential to modernization of the nation’s food safety system.  As it has done in the past, the agency can be expected to adapt its existing authorities to fulfill its objectives (e.g., GMP modernization).

Hyman, Phelps & McNamara, P.C.’s Ricardo Carvajal will be presenting "Food Safety: Unintended Components/Contaminants of Food" at the Food and Drug Law Institute's ("FDLI’s") January 24-25, 2011 conference, "Introduction to Food Law and Regulation: How the Government Regulates the Food Industry," which is part of FDLI’s Food Week 2011. The food safety session will address the adulteration provisions of the Federal Food, Drug, and Cosmetic Act, GMP’s, HACCP, low acid canned foods, control of microbial hazards in fresh produce, FDA’s retail food program, and the latest on the Reportable Food Registry.  Registration information is available here.

By Ricardo Carvajal –

FTC announced a proposed settlement with Dannon over the latter’s allegedly deceptive advertising claims for two of its probiotic products, Activia and DanActive.  FTC’s complaint alleged that Dannon explicitly or implicitly represented that one serving of Activia relieved temporary irregularity and helped with slow intestinal transit time, and that DanActive was clinically proven to help to avoid colds or flu.  Notably, the advertising described in the complaint explicitly claimed only that DanActive helps strengthen the body’s defenses in the context of a reference to immunity – a claim frequently made for many probiotic products.  Under the terms of the settlement, Dannon would forego making some claims unless they are permitted by FDA regulations, and other claims unless they are supported by “at least two adequate and well-controlled human clinical studies. . . conducted by different researchers, independently of each other, that conform to acceptable designs and protocols and whose results, when considered in light of the entire body of relevant and reliable scientific evidence, are sufficient to substantiate that the representation is true.”  

This is but the latest in a string of FTC actions that target allegedly deceptive marketing of foods.  As we noted in a prior posting, FTC has specifically signaled its interest in probiotics and immunity-boosting claims, and in products marketed for use by children.  Thus, the advertising for DanActive cited in FTC’s complaint was a “two-fer” – a probiotic with immunity-boosting claims marketed for use by children. 

According to FTC’s press release, “FTC worked in close coordination with 39 state attorneys general” who are also settling their inquiries into Dannon’s advertising to the tune of $21 million – a welcome infusion to cash-strapped states.

By Ricardo Carvajal –

A class action lawsuit has been filed in California alleging that the McDonald’s Corporation engages “in the unfair, unlawful, deceptive and fraudulent practice of promoting and advertising McDonald’s Happy Meal products to very young California children, using the inducement of various toys.”  The Center for Science in the Public Interest ("CSPI") is representing the named plaintiff as a non-profit law firm, thus making good on its threat of legal action if McDonald’s didn’t stop using toys in its marketing.  In the words of the complaint:

• McDonald’s exploits very young California children and harms their health by advertising unhealthy Happy Meals with toys directly to them. Children eight years old and younger do not have the cognitive skills and the developmental maturity to understand the persuasive intent of marketing and advertising.
• Children nonetheless influence the purchasing decisions of their parents. McDonald’s exploits that influence, by bombarding children with advertisements for Happy Meals with toys, knowing that it will result in kids nagging parents to purchase nutritionally poor Happy Meals for their children.
• These marketing practices are unfair to parents as well as their children because they interfere with the parents’ ability to instill good eating habits in their children and because they cause conflict between parents and their children.
• McDonald’s is engaged in a highly sophisticated scheme to use the bait of toys to exploit children’s developmental immaturity and subvert parental authority.

No word yet on whether additional actions will be filed that target the use of playlands and clowns as child bait.

Correction: In our original posting, we referred to CSPI as a plaintiff.  CSPI is not a plaintiff, but rather is representing the named plaintiff as a non-profit law firm.

Hyman Phelps & McNamara, P.C. is pleased to announce that Diane B. McColl has been elected Vice-President of the Council of the International Society for Regulatory Toxicology and Pharmacology (“ISRTP”).   ISRTP provides an open public forum for policy makers and scientists promoting sound toxicologic and pharmacologic science as a basis for regulation affecting human safety and health, and the environment.  The Society’s official journal is the Regulatory Toxicology and Pharmacology Journal. 

By Riëtte van Laack –

The Animal Drug User Fee Amendments of 2008 (“ADUFA”) directs FDA to prepare annual summaries of antimicrobials sold or distributed for use in food-producing animals.  The data are derived from information sponsors of new animal drug applications provide to FDA (as required by Sectin 105 of ADUFA).  Last week, FDA published its first annual report summarizing the data.  The report shows that approximately 29 million pounds of antibiotics for use in food-producing animals were sold in 2009.  More than 9 million pounds of the antibiotics were tetracyclines.  The report does not include anti-fungal or anti-viral drugs because, with the exception of formalin and hydrogen peroxide water immersion products, no approved anti-fungal or anti-viral products for use in food-producing animals were marketed in 2009.

The data on antimicrobial drugs sales and distribution information are intended to assist FDA in the Agency’s evaluation of antimicrobial resistance trends as well as FDA’s  analysis of other issues that may arise relating to the safety and effectiveness of antimicrobial drugs approved for use in food-producing animals.  Because this is the first report, meaningful trend analysis are not yet possible.

By Kurt R. Karst –      

Earlier this week, Senate Appropriations Committee Chair Senator Daniel Inouye (D-HI), released the text of the proposed Fiscal Year 2011 Omnibus Appropriations Act.  The almost 2,000-page bill, if enacted, would fund the government until September 30, 2011.  In addition to an increase in funding for FDA ($37.5 million more than the President’s request) and the FDA Food Safety Modernization Act, buried in the bill are provisions intended to promote the development and approval of products for rare and neglected diseases (as well as an increase in funding for the orphan drug grants program and funding for the Office of the Associate Director for Rare Diseases).  Specifically, Section 743 of the bill provides:

SEC. 743. (a) When implementing the authority provided in paragraphs (2) and (3) of section 740(c) of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2010 (Public Law 111–80) that requires the Commissioner of Food and Drugs to develop updated guidance documents and review standards for the development of safe and effective products to treat rare diseases and neglected tropical diseases, the Commissioner shall —

(1) maximize the use of accelerated approval where feasible and appropriate;

(2) work with sponsors to facilitate expanded access to investigational therapies;

(3) increase coordination and interaction with the World Health Organization, European Medicines Agency, and other international regulatory agencies;

(4) implement mechanisms for enhanced collaboration between the Food and Drug Administration and National Regulatory Authorities in developing countries;

(5) develop guidance on clinical development programs for rare diseases;

(6) develop guidance on the use of surrogate endpoints that are reasonably likely to predict clinical benefit of drugs and biological products under the regulations under subpart H of part 314 of title 21, Code of Federal Regulations and subpart E of part 601 of title 21, Code of Federal Regulations; and

(7) increase coordination among individual drug, biological product, and device review divisions across Food and Drug Administration centers to support the development of safe and effective medical products for rare and neglected diseases.

(b) The Commissioner of Food and Drugs shall submit a report to the Committee on Appropriations of the Senate and the Committee on Appropriations of the House of Representatives not later than 180 days after the report required in section 740(c)(1) of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2010 (Public Law 111–80) is submitted: Provided, That the report submitted in response to this section shall describe in detail how the Food and Drug Administration is implementing subsection (a).

This same provision was included in the FY 2011 Agriculture, Rural Development, FDA, and Related Agencies Appropriations bill (S. 3606) introduced earlier this year (see our previous post here), and has thus far survived the omnibus appropriations chopping block.   The Senate is expected to take up the omnibus appropriations bill this week.  If it passes in the Senate it will go to the House of Representatives as a substitute for the full-year Continuing Resolution the House passed earlier this month.

By Kurt R. Karst – 

When we last left you in the battle over FDA’s approval of a generic version of sanofi-aventis U.S. L.L.C.’s (“sanofi’s”) blockbuster anti-coagulant drug LOVENOX (enoxaparin sodium injection), Judge Emmet G. Sullivan of the U.S. District Court for the District of Columbia denied sanofi’s Motion for Preliminary Injunction.  Sanofi did not appeal the decision, but the case has moved forward for a decision on the merits.  In a Motion for Summary Judgment sanofi filed earlier this week, the company continues to allege that that FDA’s approval of generic LOVENOX is unlawful and should be set aside.  Sanofi’s brief also highlights some interesting disagreements that allegedly took placed within FDA on generic LOVENOX.

Sanofi sued FDA on July 26th requesting that the court issue a declaratory judgment that FDA acted unlawfully in approving Sandoz Inc.’s ANDA No. 77-857, as well as a temporary restraining order and preliminary injunction directing FDA to immediately suspend and withdraw approval of the ANDA, and a permanent injunction under the same terms.  (Sanofi later agreed to consolidate its temporary restraining order request with its preliminary injunction request.)  In addition to the approval of ANDA No. 77-857, Sanofi also challenged FDA’s July 23rd response to a February 2003 citizen petition, in which the Agency outlined five criteria (i.e., standards for identity) that an ANDA applicant needs to demonstrate sameness of its active ingredient as compared to LOVENOX.  Those five criteria are: (1) equivalence of physicochemical properties; (2) equivalence of heparin source material and mode of depolymerization; (3) equivalence in disaccharide building blocks, fragment mapping, and sequence of oligosaccharide species; (4) equivalence in biological and biochemical assays; and (5) equivalence of in vivo pharacodynamic profile. 

In sanofi’s initial court filings the company set forth three merits arguments as to why a preliminary injunction is necessary: (1) FDA exceeded its authority under the FDC Act (specifically FDC Act § 505(j)(2)(A)) by requiring Sandoz to submit studies beyond what is permitted for ANDAs (i.e., immunogenicity studies that, according to Sanofi, are studies intended “to demonstrate safety and effectiveness,” rather than, as FDA argued, chemistry, manufacturing, and control information); (2) FDA departed from Agency precedent by approving ANDA No. 77-857 when the product has not yet been fully characterized; and (3) FDA approved ANDA No. 77-857 without sufficient evidence that the drug product has the “same” active ingredient as LOVENOX (as required by FDC Act § 505(j)(2)(A)). 

Judge Sullivan noted in his denial of sanofi’s Motion for Preliminary Injunction that the court’s decision was not a final decision on the merits and that “Sanofi may be able to establish that there are grounds for overturning the grant of Sandoz’s ANDA.”  Sanofi’s Motion for Summary Judgment tries to do just that, building on the company’s previous merits arguments.  According to sanofi’s latest motion:

First, the plain language of the FDCA precludes FDA from requiring immunogenicity testing, as it did here, as part of the ANDA approval process. Section 505(j)(2)(A) of the Act sets forth eight categories of information FDA is permitted to require of an ANDA applicant and expressly forbids FDA from mandating submission of additional information.  Immunogenicity testing is not encompassed by any of the categories.  FDA’s argument to the contrary – that a provision of the Act authorizing it to require “a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of [a generic] drug,” encompasses immunogenicity testing – does not withstand scrutiny.  FDA’s interpretation of the FDCA would upset the three-tiered framework Congress crafted for approval of new drugs and render Section 505(b)(2) of the Act wholly superfluous.

Second, FDA’s decision must be set aside as arbitrary and capricious under the [Administrative Procedure Act] because of the Agency’s utter failure to acknowledge and provide a persuasive justification for its departure from established precedent. . . .  Prior to its unlawful approval of Sandoz’s ANDA, FDA had consistently recognized that where a drug is not fully characterized, it is impossible to conclude that it is the same as a previously approved drug. . . .

Third, and finally, FDA’s approval decision is flatly inconsistent with the FDCA’s mandate that an ANDA may not be approved unless its active ingredient is the “same as” that of the RLD.  In contravention of this statutory directive, FDA approved Sandoz’s ANDA based on application of a five-factor test that relies on unsubstantiated conjecture lacking any basis in either science or the text of the FDCA.  Moreover, the evidence before the Agency makes clear that Sandoz’s drug did not even satisfy the Agency’s own ad hoc standard for determining active ingredient sameness. [(Internal citations omitted)]

Sanofi’s Motion for Summary Judgment also brings to light some interesting tensions within FDA concerning the five criteria that an ANDA applicant needs to demonstrate sameness of its active ingredient as compared to LOVENOX.  According to sanofi, information in the administrative record shows that scientists within FDA’s Office of New Drug Quality Assessment (“ONDQA”) “expressed disagreement” with the Office of Generic Drugs’ (“OGD’s”) conclusions about the five criteria for assessing active ingredient sameness in generic LOVENOX.  According to sanofi:

ONDQA’s scientists, including FDA’s own expert on heparin and heparin-based products, Dr. Ali Al Hakim, explained that a showing of active ingredient sameness for enoxaparin is impossible without complete characterization of all of enoxaparin’s oligosaccharide chains.  ONDQA argued that, because enoxaparin consists of a mixture of oligosaccharides, it cannot be determined which components of the mixture contributed to enoxaparin’s activity.  ONDQA further explained that OGD’s five criteria are inadequate to demonstrate sameness and criticized OGD for relying on “inference” to do so.   ONDQA asserted that OGD’s proposed methodology was contrary to both the law and FDA policies.  [(Internal citations omitted)]

This disagreement was resolved in a July 20, 2010, intra-agency memorandum, according to sanofi, in which Dr. Keith Webber, Deputy Director of the Office of Pharmaceutical Science (and acting OGD Director) determined that the five criteria are a “valid approach . . . for purposes of ANDA approval.”  According to sanofi, Dr. Webber “[rejected] ONDQA’s argument that OGD’s approach was inconsistent with FDA policy involving drugs that had not been fully characterized [and] asserted that ‘[d]epending on the kind of drug at issue, there may be different ways to show active ingredient sameness’ and that OGD’s approach was acceptable as applied to enoxaparin.”

FDA’s five criteria for assessing active ingredient sameness with respect to generic LOVENOX were also raised in a December 10th citizen petition submitted on behalf of Teva Neuroscience, Inc. (“Teva”) concerning FDA’s ability to approve generic versions of the company’s COPAXONE (glatiramer acetate injection), a drug product approved for the reduction of frequency of relapses in relapsing-remitting multiple sclerosis.  In May 2010, FDA indicated in a response to a different Teva citizen petition concerning generic COPAXONE that the Agency might be considering applying similar criteria to that drug.  Specifically, FDA stated that “given the complexity of Copaxone, we may require that any ANDA sponsor demonstrate active ingredient sameness through a multi-criteria test or series of tests, each criterion of which captures different aspects of the active ingredient’s ‘sameness,’ and which together would provide overlapping evidence by which an ANDA applicant could demonstrate active ingredient sameness within the meaning of the Act and FDA regulations.” 

Teva argues in its latest petition, among other things, that “none of the five criteria that provided reasonable assurance of sameness between generic enoxaparin and Lovenox® are viable in the Copaxone® context” (emphasis in original), and that generic COPAXONE should not be approved unless and until: (1) the glatiramer acetate in COPAXONE has been fully characterized and a generic applicant proves that its proposed drug product contains exactly the same polypeptide sequences (in the same amounts and with the same structures) as COPAXONE; or (2) all polypeptide sequences that contribute to the therapeutic effects of COPAXONE’s glatiramer acetate have been identified and a generic applicant proves that its proposed drug product contains exactly the same clinically relevant polypeptide sequences (in the same amounts and with the same structures) as COPAXONE (and that any differences in the non-clinically active polypeptides in the proposed generic drug do not “undermine the clinically active polypeptides’ safety, efficacy, toxicology, and immunology profiles”). 

By Kurt R. Karst –      

Last Friday, Teva Pharmaceuticals USA, Inc. (“Teva”) filed its opposition brief to Apotex, Inc.’s (“Apotex’s”) Petition for Writ of Certiorari, which Apotex filed with the U.S. Supreme Court in October asking for a review of the U.S. Court of Appeals for the District of Columbia Circuit’s decision involving Teva’s 180-day exclusivity for generic versions of Merck’s COZAAR and HYZAAR (i.e., losartan).  Teva’s 180-day exclusivity for losartan expired on October 3, 2010, the day before Apotex filed its petition with the Supreme Court. 

Apotex’s petition arises from the D.C. Circuit’s March 2, 2010 decision in Teva Pharms USA, Inc. v. Sebelius.  In that case, a 3-judge panel of the D.C. Circuit ruled in a 2-1 decision concerning 180-day exclusivity for losartan that there is “no reason to conclude that the 2003 addition of forfeiture provisions meant to give the brand manufacturer a right to unilaterally vitiate a generic’s exclusivity.”  Thus, a mere patent delisting request is not enough to trigger a forfeiture event under the failure-to-market forfeiture provision at FDC Act § 505(j)(5)(D)(i)(I). 

In July 2010, in separate litigation, a 3-judge panel of the D.C. Circuit issued a per curiam judgment affirming the U.S. District Court for the District of Columbia’s April 2, 2010 order denying motions for preliminary injunction filed by Roxane Laboratories, Inc. (“Roxane”) and Apotex.  The Roxane and Apotex motions challeged FDA’s March 26, 2010 letter decision in which the Agency reluctantly concluded that, as a result of the D.C. Circuit’s March 2, 2010 decision in Teva Pharms USA, Inc. v. Sebelius, Teva did not forfeit 180-day exclusivity eligibility.  (For additional background on the litigation over 180-day exclusivity for losartan see our previous post here.)

As an initial matter, Teva argues that Apotex’s petition should be denied because it moot, and therefore, dead on arrival:

Apotex’s complaint — and the preliminary injunction motion addressed by the sole D.C. Circuit decision at issue here — sought only prospective relief challenging Teva’s entitlement to 180-day marketing exclusivity.  But Teva’s 180 days of exclusivity have come and gone, and while this Court can do many things, it can’t turn back time.  There is thus no case or controversy left for the Court to resolve; any opinion regarding the merits would be purely advisory.

Nor, according to Teva, does the case present an exceptional situation involving an issue that is “capable of repetition while evading review:” 

Though Apotex has identified a handful exclusivity-grounding patents that the brand manufacturer deliberately let lapse, there is no reason why the question it seeks to raise here will evade review if, as Apotex speculates, it ever arises again. After all, challenges to the legal rules FDA applies in making exclusivity decisions can be brought well before an exclusivity period is scheduled to begin — and with ample time for this Court to review the issue Apotex seeks to raise in a case where it actually matters. [(Internal citations omitted)]

Even if the case were not moot, “it would be a poor vehicle to address the question it purports to present, because it arises in the interlocutory context of a preliminary injunction proceeding,” states Teva.  The lack of a circuit split “on the issue Apotex purports to raise” and that “Apotex in any event exaggerates the likelihood that it will recur” are separate grounds on which the Court should deny the petition, according to Teva. 

Finally, Teva argues that there is no need for the Supreme Court to grant review because the D.C. Circuit’s preliminary analysis of the merits was correct: 

As three different panels of the D.C. Circuit now have recognized, it upends both law and logic to think that Congress created an elaborate incentive scheme designed to encourage generic companies to challenge dubious brand-name patents, but simultaneously empowered the brand companies who assert those dubious patents to eviscerate that incentive scheme.  In short, because Apotex’s interpretation of the statute would allow brand companies to manipulate the exclusivity incentive despite the absence of any suggestion in the text, history, or structure of the statute that Congress intended to give brand companies that power, the D.C. Circuit properly held that Apotex was unlikely to prevail on the merits.

The case, Apotex, Inc. v. Sebelius, is docketed as Case No. 10-453.  AARP filed an amicus brief in the case on November 4th.

By Riëtte van Laack –

FDA published a proposed rule that would amend the regulation governing the use of health claims for phytosterols and coronary heart disease.  In 2000, FDA issued an interim final rule ("IFR"), 21 C.F.R. § 101.83, for health claims concerning the relationship between plant sterol/stanol esters and the reduced risk of CHD.  In 2003, the Agency issued a letter announcing that it would exercise enforcement discretion concerning certain claims that went beyond the claims permitted by the IFR ("2003 letter").  Since then, new evidence has become available concerning the effects of stanol and sterols in the esterified and non-esterified form (primarily evidence from numerous intervention studies), and FDA has received several requests for expansion of the health claim.  Because the public has not had a formal opportunity to comment on FDA’s proposed changes (as well as those announced in the 2003 letter), and because it has been ten years since the Agency published its IFR, FDA decided to issue a proposed rule rather than finalize the IFR. 

The proposed rule includes the following significant changes to 21 C.F.R. 101.83:

• A broadening of the substances eligible for the health claim for conventional foods to include any mixtures of esterified and nonesterified phytosterols (defined as inclusive of both sterols and stanols) derived from vegetable oils and tall oil.
• Removal of the restrictions on types of conventional foods eligible for the claim.
• Setting the daily dietary intake of phytosterols necessary to justify the claim for risk reduction at 2 g phytosterols per day.
• A requirement that food eligible for the claim contains 500 mg phytosterols per serving (provided that the phytosterols are GRAS at this use level).
• A requirement that the phytosterol-containing product must be consumed with meals or snacks.
• A limitation of the exception from the disqualifying fat level (13 g of fat per serving size or per 50 g of food) to vegetable oil spreads that resemble margarine, and inclusion of liquid vegetable oil in the short list of exceptions.
• The addition of liquid vegetable oils to the products exempt from the “minimum nutrient requirement” (i.e., foods eligible for a health claim must contain no less than 10% of the  Reference Daily Intake or Daily Reference Value for vitamin A, C, iron, calcium, protein or fiber per reference amount without nutrient addition).  Vegetable oil spreads resembling margarine may meet the minimum nutrient requirement by addition of vitamin A.

In the absence of valid scientific evidence, claims for dietary supplements remain limited to dietary supplements containing esterified phytosterols.  The requirement that conventional foods must be eligible for the claim “low in saturated fat” and “low in cholesterol” also remains.  

FDA did not propose a limit on trans fat content of food eligible for the health claim.  The Agency, however, requests input on the setting of a limit based on a single study that showed an effect of phytosterols in the presence of 0.8 g/day of trans fat. 

FDA notes that its proposal should not be interpreted as a statement that foods containing certain phytosterols do not violate § 301(ll) of the Federal Food, Drug and Cosmetic Act.  For more on the potential impact of section § 301(ll), click here.

FDA intends to exercise enforcement discretion with respect to claims that comply with the proposed rule.  However, beginning 75 days from December 8, 2010, FDA will no longer exercise enforcement discretion based on the 2003 letter.

Written comments may be submitted through February 22, 2011.

June Stephenson, a 37-year employee in FDA’s Office of Chief Counsel, will retire on December 31, 2010.   Ms. Stephenson has been the principal secretary for every chief counsel at FDA since 1974.  At a December 8th retirement party, her contributions were recognized by almost all of the nine chief counsels with whom she worked (including Hyman, Phelps & McNamara’s Tom Scarlett), and she received the Distinguished Career Service Award from the FDA Commissioner and a Certificate of Appreciation from the HHS Secretary.  The previous night, the Food and Drug Law Institute awarded Ms. Stephenson with a Lifetime Achievement Award. 

Those of us in the private sector who have dealt with the Office of Chief Counsel these past 37 years will miss her as much as her FDA colleagues.  We have appreciated the gracious professionalism she exhibited while dealing with us.  The courteous and intelligent face she presented to all with whom she came in contact enhanced FDA’s  reputation.  We wish her a long and happy retirement!

By Susan J. Matthees –

Last Tuesday, FDA announced the availability of final results from its experimental study of graphic cigarette warning labels.  As we previously reported, FDA proposed 36 graphic warning images to accompany the health warning statement required under section 201 of the Family Smoking Prevention and Tobacco Control Act.  As part of that process, FDA conducted a study of smokers ages 18 and older and youth ages 13 to 17 who were identified as being at risk for smoking.  Participants were divided into a control and a test group, with the control group seeing only the worded warning and the test group seeing the worded warning and the images.  After seeing the warnings or the warnings plus images, participants were asked about their reactions, related attitudes and beliefs about the risks of smoking, and intentions to quit or start smoking. 

The results of the study were mixed.  Although nearly every graphic image was associated with a higher emotional response than words alone and many of the images were associated with an increased recall of the message, only a few images actually had an influence on the participants’ beliefs about the health risks of cigarettes or the participants’ likelihood of quitting or not starting smoking.  In fact, some of the images were negatively associated with beliefs about health and behavior (i.e., participants were less likely to believe that smoking was dangerous or were less likely to consider quitting after viewing the image).  In its analysis, FDA opined that participants may need to see a certain “dose” of images before the images would have an actual impact on beliefs and behaviors.

The report made no conclusions on which images, if any, would ultimately be selected for use on cigarette labels.

By Kurt R. Karst –      

Earlier today, the U.S. Supreme Court granted certiorari in three cases concerning generic drug preemption - PLIVA Inc. v. Mensing (09-993), Actavis v. Mensing (09-1039), and Actavis v. Demahy (09-1501).  As we previously reported, the petitions presented almost identical questions for the Supreme Court’s consideration: “Whether the Eighth Circuit [, in its November 27, 2009 decision in Mensing v. Wyeth, Inc.], abrogated the Hatch-Waxman Amendments by allowing state tort liability for failure to warn in direct contravention of the Act’s requirement that a generic drug’s labeling be the same as the FDA-approved labeling for the listed (or branded) drug.”

The Court decided to hear the cases notwithstanding a recommendation from the U.S. Department of Justice (Solicitor General of the United States), which filed an amicus brief in November, that the Court deny review given the current lack of a split of authority among the circuits on the issue of preemption and state law failure-to-warn claims against generic drug manufacturers, as well as several uncertainties in Mensing that “further counsel against review at this time.”

By Alan M. Kirschenbaum –

Individuals may have their tax cuts extended, but a new tax on the drug industry is about to begin in 2011, and the IRS has issued a notice to implement it.  As we explained in our summary of the Patient Protection and Affordable Care Act ("ACA"), the ACA imposes an industry-wide tax on companies that manufacture or import branded prescription drugs or biologics (i.e., those approved under an NDA or BLA) for sale in the U.S.  The aggregate annual fee for all such companies is specified in the statute, and ranges from $2.5 billion to $4.1 billion each year, then remains at $2.8 billion in 2019 and subsequent years.  Each manufacturer’s share of the fee is based on the ratio of its branded drug sales to the branded drug sales of all covered entities during the prior year.  Branded drug sales are sales of brand (i.e., NDA or BLA) prescription drugs (excluding orphan drugs) made to or reimbursed by Medicare, Medicaid, the Department of Veterans Affairs ("VA"), the Department of Defense ("DoD"), and the TRICARE retail pharmacy program. 

On November 27, the IRS issued Notice 2010-71 explaining how the drug industry fee will be implemented.  Although the statute specifies that the fee is to be based on sales during the prior year, the Notice explains that CMS is unable to provide data on Medicaid and Medicare drug utilization during a calendar year in time to set the fee for the following year.  Therefore, the sales used to establish the fee for any calendar year will be sales for the second year preceding the fee year – in other words, the sales data will be two years old.  To address the problem of basing the fee on data that is somewhat stale, the IRS proposes an adjustment to the fee that is derived from the increase (or decrease) in a company’s sales from the third to second year preceding the fee year.  Perhaps the IRS reasons that, if a drug’s sales increased (or decreased) between those two years, this justifies a presumption that sales continued to increase (or decrease) from the second to the first year preceding the fee year, so that the sales data from the second preceding year should be adjusted upward (or downward) to set the fee.

The Notice describes how sales to the VA, DOD, Medicaid, and Medicare Parts B and D will be calculated.  A company’s sales will be reduced by rebates the company paid to Medicaid (i.e., the Medicaid rebate but not Medicaid supplemental rebates) and Medicare Part D plans. 

Issued with the Notice was Form 8947, which covered manufacturers must submit to the IRS by January 20, 2011 to provide corporate information and data on orphan drugs, rebates paid to Part D plans, and other drug information.  The IRS will then provide each covered manufacturer with a preliminary fee calculation by May 2, 2011.  Comments on the Notice will be accepted until June 2, 2011, after which a final Notice will be issued.  A final fee calculation (taking into account any methodology changes) will be sent to manufacturers by August 15, 2011.

This week, the Republican Steering Committee selected Congressman Fred Upton (R-MI) to succeed Congressman Henry Waxman (D-CA) as Chair of the House Energy and Commerce Committee in the next Congress.  In August 2008, at the Democratic National Convention in Denver, Hyman, Phelps & McNamara’s Frank Sasinowski, the current chairman of the National Organization of Rare Diseases ("NORD"), had the idea to start a Congressional caucus on rare and neglected diseases in order to have a forum for issues that matter to the more than 25 million Americans with rare or orphan disorders.  Frank approached Rep. Waxman in Denver and broached the idea, which Rep. Waxman immediately supported.  Fast forward: NORD took up the idea and championed the creation of this caucus.  In forming this caucus, John Crowley, CEO of Amicus Therapeutics, (the subject of the film "Extraordinary Measures" as portrayed by Brendan Fraser), was "extraordinarily" instrumental.  Frank suggested to John that Cong. Upton be asked to co-chair the caucus.  Rep. Upton along with co-chair Rep. Joseph Crowley (D-NY) (no relation to John), announced the formation of the caucus this past July.  Now, Rep. Upton will be chairing the committee that has jurisdiction over FDA.  Orphan ideas are blossoming in December in DC!