August 2012 Archives

August 31, 2012

Pediatric Inventory Consultation Begins for Europe's Medicines

Thumbnail image for pediatrics.jpgThe Pediatric Committee ("PDCO") of the European Medicines Agency ("EMA") is tasked with identifying the needs for children in a variety of therapeutic areas and aims to encourage the research and development of pediatric medicinal products. The first Inventory, which is now open for discussion and public consultation, covers medicines for cardiovascular diseases. The EMA points out that it will be releasing similar lists for other therapeutic areas for public consultation during 2012 and 2013.

According to the EMA, the Inventory aims to enable:

  • Companies to identify opportunities for business development;
  • The PDCO to judge the need for medicines and studies when assessing draft pediatric investigation plans, waivers and deferrals; and
  • Healthcare professionals and patients to have an information source available to support their decisions as to which medicines.

The Inventory is based on a report on the survey of all pediatric uses of medicinal products in Europe completed by the PDCO in December 2010.

Continue reading "Pediatric Inventory Consultation Begins for Europe's Medicines" »

August 29, 2012

GDUFA Guidances and Public Meeting Announced

Thumbnail image for Thumbnail image for Thumbnail image for Thumbnail image for Thumbnail image for drugmoney.jpegOn August 27, FDA published a Federal Register notice announcing the availability of industry guidance for generic drug user fees entitled "Generic Drug User Fee Amendments of 2012: Questions and Answers" and "Self-Identification of Generic Drugs Facilities, Sites, and Organizations." Simultaneously with this notice, FDA also announced an upcoming public meeting on September 21, 2102 from 9 a.m. to 1 p.m. to discuss FDA's implementation of the Generic Drug User Fee Amendments of 2012 ("GDUFA"). Finally, on the same day, another related Federal Register Notice issued: "Notice of Opportunity to Withdraw Abbreviated New Drug Applications to Avoid Backlog Fee Obligations." Below is a snapshot of each of these items taken in turn.

GDUFA was signed into law on July 9, 2012 but the obligations arising therein begin on October 1, 2012. We have previously blogged on the genesis of GDUFA, when both the House and Senate passed GDUFA, for some background why and how we got here.

The GDUFA Q&A answers questions about the various types of fees (backlog fee, drug master file fee, generic drug submission fees (including a fee for active pharmaceutical ingredients ("APIs") not referenced in a drug master file), and facility fees for APIs and finished dosage forms ("FDFs")), self-identification of facilities, sites, and organizations, review of generic drug submissions, and inspections and compliance. For example, most immediately, backlog fees will be calculated based on the number of pending original abbreviated new drug applications ("ANDAs") at the start of October 1, 2012. As was mentioned in a recent conference discussing this topic, a recommendation was made for all generic applicants to "clean house" and make sure that they did not pay fees for any pending ANDAs that they were no longer pursuing. FDA explains in this Notice that in accordance with GDUFA, FDA will divide $50 million by the number of pending ANDAs pending on this day to arrive at an individual one-time backlog fee due for each pending ANDA. Applicants wishing to remove pending ANDAs from this list, however, must do so by written notification received by FDA on or before September 28, 2012. Failure to pay the backlog fee is further explained, including a public disclosure of the failure to pay, and FDA will not receive a new ANDA or supplement submitted by that applicant "or affiliate" until the fee is paid. The GDUFA Q&A also explains when the various fees will be collected and the effect of not paying those fees timely. For new ANDAs or supplements, feed need to be paid when due, e.g., for new ANDAs, within 20 calendar days of the date that FDA provides notification that failure to pay will result in the ANDA or supplement not being receive and, therefore, reviewed.

Continue reading "GDUFA Guidances and Public Meeting Announced" »

August 27, 2012

FDA Lawyers Blog Invites Your Nomination to ABA's List of Best 100 Legal Blogs

APPlogo2.pngFDA Lawyers Blog is pleased to invite you to nominate FDA Lawyers Blog to the American Bar Association's ("ABA's") annual list of the best 100 legal blogs. The short ABA's Blawg 100 Amici Form may be found here.

Nominations are due no later than September 7, 2012.

Here are the criteria to keep in mind when nominating FDA Lawyers Blog or other legal blogs to the list-straight from the ABA's website for Amici:

  • We're primarily interested in blawgs in which the author is recognizable as someone working in a legal field or studying law in the vast majority of his or her posts.
  • The blawg should be written with an audience of legal professionals or law students--rather than potential clients or potential law students--in mind.
  • The majority of the blawg's content should be unique to the blawg and not cross-posted or cut and pasted from other publications.
  • We are not interested in blawgs that more or less exist to promote the author's products and services.

The ABA discourages nominations from:

  • Blawggers who nominate their own blawgs or blawgs to which they have previously contributed posts.
  • Wives and husbands who nominate their spouses' blawgs.
  • Employees of law firms who nominate blawgs written by their co-workers.
  • Public relations professionals in the employ of lawyers or law firms who nominate their clients' blawgs.
  • Pairs of blawggers who have clearly entered into a gentlemen's agreement to nominate each other.
Thank you for reading FDA Lawyers Blog. We have been running for more than two years strong and plan to keep it that way. We also invite you to send us a comment through the blog if there are topics or things that you think we could do better. For example, in addition to our unique resources on Biosimilars and European Drug Law, what additional resources would be useful for you?

We are constantly trying to improve our blog as well as how it interfaces with you. Last year, we were one of the first blogs to introduce Mobile Applications for iPhones and Android that not only delivered blogs from FDA Lawyers Blog but also key FDA news feeds and a phone-ready HHS directory. A few weeks later, we introduced our custom-designed mobile style sheets for FDA Lawyers Blog to optimize your viewing experience of the Blog on any smartphone or mobile device, whether or not one of the apps were downloaded. This year we continued our trail-blazing trend to incorporate Google+ into our social media platform that already included Facebook, Twitter, and LinkedIn. And we did not stop there. We then customized our Contributors' profiles to flow more like an electronic resume to make them more readable for business professionals. Last week, we revised our "About" section to incorporate additional information about the FDA/Regulatory Group at Frommer Lawrence and Haug LLP.

We look forward to continuing to blog about FDA news and topics that interest you and keep you on top of new developments. Thanks for reading!!!

August 24, 2012

Intelliject/Sanofi Auvi-Q™ Device Receives FDA Approval

On August 10, 2012, FDA approved Intelliject's new drug application for Auvi-Q™ (epinephrine) Auto-injector, a device used for the emergency treatment of life-threatening allergic reactions, or anaphylaxis. Anaphylaxis is a severe whole-body reaction to an allergen, characterized by difficulty breathing/wheezing, reductions in blood pressure and pulse, hives/itchiness, swelling of the face, among other symptoms. Anaphylaxis occurs very rapidly, often within seconds or minutes of exposure, and can result in death without prompt medical attention. Epinephrine is the only first-line treatment for anaphylaxis, based on its ability to regulate heart rate, blood vessel and airway passage diameters, and metabolic shifts.

Currently, the EpiPen® Auto-injector is the most prescribed treatment for severe allergic reactions and anaphylaxis, with a market share of more than 95%. However, close to two thirds of patients and caregivers do not carry EpiPens® at all times as directed. Further, many patients have concerns that others will not know how to use EpiPens® in an emergency situation. Other epinephrine auto-injectors, similar in shape to EpiPen®, include Twinject®, Adrenaclick®, and Anapen®.

Unlike the currently-available auto-injectors, Auvi-Q™ is the size and shape of a credit card, and it is as thick as a smartphone, making it small enough to fit in a pocket or a small purse. In addition, Auvi-Q™ is the first epinephrine auto-injector to provide both audio and visual instructions to direct a user how to properly use the device. Intelliject's goal for AuviQ™ was to make it easy to carry and easy to use.

Continue reading "Intelliject/Sanofi Auvi-Q™ Device Receives FDA Approval" »

August 23, 2012

Learn the FDA Approval Process and the Ins and Outs of Post-Approval Challenges for Medical Devices

Thumbnail image for Thumbnail image for aci_header_banner.gifNow in its second year, ACI's FDA Boot Camp - Devices Edition has been designed to give products liability litigators, as well as industry in-house counsel, federal and regulatory affairs professionals, and life sciences investment and securities experts, a strong working knowledge of core FDA competencies. Learn from an experienced faculty of FDA regulatory attorneys whose sole purpose is to provide you with the information you need to remain compliant and in command. Don't wait until 2013 to hone your practice and to hear from a stellar faculty, led by a "who's who" of the nation's leading medical device regulatory lawyers, who will help you understand:

  • The basics of the application and approval processes, including 510(k) clearance and PMAs
  • The complexities of device regulations
  • The structure of the FDA and the roles of the three major agency centers: CDER, CBER, and CDRH
  • A practical working knowledge of clinical trials and IDEs
  • How devices are classified, monitored, and regulated
  • The pivotal role of labeling and learn how to avoid misbranding and off label promotion
  • The importance of cGMPs and QSRs to the post-approval regulatory process
  • The protocols of adverse events monitoring, product withdrawals, and recalls

Attend the pre-conference workshop to seamlessly join the FDA regulatory law discussions at the main conference. The perfect primer to accompany FDA Boot Camp, the pre-conference workshop: Fundamentals of FDA Device Regulatory Law, provides the FDA law refresher course essential to getting the most benefit from the main conference program.

Continue reading "Learn the FDA Approval Process and the Ins and Outs of Post-Approval Challenges for Medical Devices" »

August 21, 2012

FLH Partner Malkin Quoted in FDANews Article on K-Dur® Pay-for-Delay Ruling

Thumbnail image for Money in hand.jpgOn August 21, FLH Partner Brian J. Malkin was quoted in an FDAnews Article on a August 17 ruling refusing to stay a ruling regarding a settlement for K-Dur® 20 (potassium chloride) that was found to be presumptively anticompetitive. As part of the settlement in question, Upsher-Smith Laboratories ("Upsher-Smith") did not agree that the patent-at-issue was valid, infringed, and enforceable, but did agree to refrain from marketing its generic potassium chloride supplement or any similar product until September 1, 2001, when it would receive a non-royalty, non-exclusive license under the patent to make and sell its generic version. Upsher-Smith also granted the innovator, Schering-Plough Corporation ("Schering-Plough") a license to several Upsher-Smith products, including Niacor-SR, a sustained niacin product. Schering-Plough also agreed to pay Upsher-Smith $60 million over three years plus additional royalties depending on its sales of Niacor-SR. After the settlement, however, Schering-Plough abandoned its plans to market Niacor-SR.

The Third Circuit originally held:

Specifically, the finder of fact must treat any payment from a patent holder to a generic patent challenger who agrees to delay entry into the market as prima facie evidence of an unreasonable restraint of trade, which could be rebutted by showing that the payment (1) was for a purpose other than delayed entry or (2) offers some pro-competitive benefit.
For more background on this case, please see one of our blogs here.

Malkin was cited in the article in the following manner:

Both brand and generic-drug makers are likely to try to find more creative ways to craft settlements if pay-for-delay deals are ultimately found to violate antitrust law, Brian Malkin a partner at Frommer Lawrence & Haug, told DID. For example, such settlements could involve more than just the drug product at issue in the case, making it less clear whether there is a pay-for-delay element.

A high court ruling against pay-for-delay could also affect companies' willingness to litigate certain patent cases, Malkin added.

Meanwhile, Congress may be waiting to see if and how the Supreme Court rules on this issue, Malkin said. A representative from Sen. Orrin Hatch's (R-Utah) office told him earlier this year that legislation targeting pay-for-delay deals is "likely on the backburner."

Meanwhile, Defendants Merck & Co. Inc. (the successor-in-interest after Schering-Plough) and Upsher-Smith have asked the U.S. Supreme Court to look into the Third Circuit's pay-for-delay ruling. In particular, the K-Dur ruling differs from other circuits that have found such payments legal in the context of a patent that is presumptively valid and an agreement to market by the expiration date of the patents-at-issue in return for ending the litigation. The U.S. Federal Trade Commission ("FTC") Chairman, Jon Leibowitz, has reportedly commended the Third Circuit for having "gotten it just right" in K-Dur,as the FTC plant to expand the holding into other cases pending in the Third Circuit and possibly other circuits pending the Supreme Court's deliberation whether to hear the appeal.

August 16, 2012

Clinical Study Report Tightening in New Proposed Legislation

Thumbnail image for 3699948229_d7732f8df0_o.jpgOn August 2, four members of the House of Representatives, led by Congressman Edward Markey, introduced, H.R. 6272, "The Trial and Experimental Studies Transparency (TEST) Act of 2012." The TEST Act will amend Section 402(j) of the Public Health Service Act, tightening the reporting requirements for the Internet site designed to better inform the public about ongoing and completed clinical trials in the United States, The main goal of the TEST Act is to prevent clinical-trial sponsors from withholding negative study data and safety concerns while emphasizing the positive results of their clinical trials.

Prior to the proposed TEST Act, under the Food and Drug Administration Amendments Act of 2007 ("FDAAA"), most United States-conducted interventional clinical trials were registered at, and most of the results of those clinical studies were eventually published. However, loopholes in the requirements of the FDAAA resulted in clinical studies that were either not registered, that failed to report results, or both. There are a number of clinical trials, therefore, that are not registered in the publically-accessible database.

The TEST Act will require all interventional biomedical studies conducted on humans to be registered on prior to enrolling any patients. In addition, sponsors of these clinical trials will be required to post the study results and other required information on within one year of the completion date of the trial. According to the proposed legislation, interventional studies include all human studies where patients are assigned, via protocol, by an investigator to receive specific intervention where the effects of such intervention on biomedical or health-related outcomes are evaluated. For clinical trials involving drugs or medical devices that have never been approved for any use, the TEST Act permits a delayed results submission of up to two years from the date of completion of the clinical trial.

Continue reading "Clinical Study Report Tightening in New Proposed Legislation" »

August 13, 2012

Federal Circuit Weighs in on Use Code Remand

Thumbnail image for Thumbnail image for Thumbnail image for federalcircuit.jpgThe U.S. Court of Appeals for the Federal Circuit recently rendered a follow-up ruling on remand from the Supreme Court's April 2012 decision regarding Orange Book use codes for method-of-use patents Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S. The Federal Circuit held, in a July 30 ruling, that: (i) a district court can issue a mandatory injunction requiring the owner of the NDA for the brand product to correct a use code which inaccurately describes the FDA-approved, patented use, but (ii) the court must first give the NDA holder the opportunity to correct the use code, rather than direct the company to use precise language for the code.

Nevertheless, the Circuit went on to state: (i) the NDA holder does not have "unbounded discretion" in proposing a new use code, and (ii) the district court has the power to construe the scope of the patent claims and provide limits on the appropriate scope of the corresponding use code. If the court determines that the new code is inaccurate and/or overbroad, the judge at that point can correct the error.

This latest development comes in the wake of the U.S. Supreme Court's decision arising from Caraco's proposed section (viii) labeling carve-out for use of the diabetes drug repaglinide (on which we have previously reported here, for example). The patent at issue claimed use of repaglinide in combination with the drug metformin. Caraco wanted to omit the combination therapy, and label its generic version to treat diabetes with repaglinide only. Novo Nordisk admitted that the patent did not cover the use of repaglanide alone, but then changed its use code in the Orange Book to wording that was broad enough to cover repagalanide alone.

Continue reading "Federal Circuit Weighs in on Use Code Remand" »

August 9, 2012

Genzyme's Synvisc-One® Patent Found Not infringed and Invalid by Jury

knee.jpgOn August 3, a jury in the U.S. District Court for the District of Massachusetts found Genzyme's U.S. Patent Number 7,931,030 ("the '030 patent) was both not infringed by Seikagaku Corp. and its U.S. distributor, Zimmer Inc., and invalid as obvious in light of the prior art.

Genzyme obtained FDA approval in February 2009 to market Synvisc-One®, an injectable hyaluronic acid gel to treat osteoarthritic pain in the knee. According to Genzyme, Synvisc-One® was an improvement over prior treatments since only one injection of Synvisc-One® was required at least every six months compared to existing drugs that require three injections one week apart for similar pain relief. Synvisc-One® was the only single injection treatment until the FDA approved Gel-One®, a similar treatment also containing hyaluronic acid produced by Seikagaku, in March 2011. One month later, Genzyme filed a complaint alleging that Gel-One® infringed U.S. Patent Number 5,399,351 ("the '351 patent"). Genzyme then amended its complaint to add the '030 patent to the suit in June 2011 and agreed to drop claims concerning the '351 patent in February 2012.

Following this jury verdict, U.S. District Judge Douglas Woodlock vacated a preliminary injunction issued on December 30, 2012 barring Zimmer from providing free samples of Gel-One® and from selling Gel-One® at less than $547.60 per injection. Judge Woodlock also refused to grant a judgment as a matter of law after the jury verdict.

The use of a jury in this case as opposed to a bench trial in front of a judge is consistent with the significant increase in the use of juries in patent cases since the 1980s according to a 2011 Patent Litigation Study by PricewaterhouseCoppers. However, the outcome in this trial, favoring in the alleged infringer, is contrary to the general trend demonstrating that patent holders are more likely to win in front of a jury instead of a judge according to the same study.

August 6, 2012

Pediatric Study Exclusivities Reauthorized to Encourage Development of More Pediatric Drug Information

pediatrics.jpgThere has been an increased effort to increase pediatric testing for adult medications, due to the expense of pediatric clinical trials and parent concerns about participation. For example, an alarming 70 percent of medications prescribed for children have never been tested on them, the National Institute of Health ("NIH") estimates.

In an effort to address the issue, on July 9, 2012, President Barack Obama reauthorized the "Best Pharmaceuticals for Children Act" and "Pediatric Research Equity Act" providing drug companies with a six month period of "pediatric exclusivity" if they perform studies approved by the FDA. This approval is a main proponent in easing parents' minds when allowing their own children to participate in clinical trials. In addition, such initiatives have helped incentivize sponsors to conduct more pediatric research with NIH funding for pediatric research rising by 18% "from $2.77 billion in 2008 to $3.28 billion in 2011.

Written by Elizabeth Barker

Other Posts By This Author

Still, while improvements are on the horizon, there is much to be done to fully address the lack of pediatric clinical trials. A July 23 study in Pediatrics found a scarcity in pediatric drug trials as well. Dr. Florence T. Bourgeois, lead researcher on the new study, expressed concern that doctors have long been known to "extrapolate" findings from adult studies to then apply them to children. Bourgeois said that "children are not small adults." Due to children's developing bodies, they metabolize drugs differently than adults do. In fact, children encounter disease just as frequently, or more so, than adults, according to Bourgeois, yet "[c]hildren continue to be underrepresented in clinical trials compared with their burden of disease." Overall, just 12 percent of all clinical trials focused on children and teenagers. Yet children accounted for 60 percent of those suffering the conditions studied. Bourgeois said that more may need to be done to encourage not only drug company trials, but studies funded by non-commercial sources as well.

"One of FDA's top priorities is giving pediatricians and parents the same level of tested and researched information on drugs used to treat children that is required for drugs used to treat adults," FDA spokesperson Sandy Walsh reportedly said. "Congress has helped increase studies for children by passing legislation that gives companies financial incentives to conduct pediatric studies and to require them to study a product they are developing for adults if the disease also occurs in children," Walsh added.

The impact and influence of the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act will be discussed by FDA's Pediatric Advisory Committee this upcoming September. The meeting agenda includes the discussion of pediatric-focused safety reviews as mandated by both of the recently authorized Acts.

August 3, 2012

Malkin Quoted in MedPage Today Article Regarding New GPhA Study Highlighting Generic Drug Successes and Hopes for Developing a Generic Biological Market

gpha-headerLogo.gifYesterday, FLH Partner Brian J. Malkin was quoted in a MedPage Today article by Washington Correspondent David Pittman on a GPhA Study that also published yesterday entitled: "Savings $1 Trillion Over 10 Years: Generic Drug Savings in the U.S. (Fourth Annual Edition: 2012)". According to the Report, generic drug use has saved the U.S. health care system approximately $1.07 trillion over the past decade (2002 through 2011) with $198.8 billion in savings in 2011 alone. The GPhA Report in turn referenced a number of recent positive analyses of the generic industry, asking Congress not to change the innovator-generic incentives or restrict the use of generics, with a promise for delivering generic biologicals in the future.

Along these lines, MedPage Today attributed Malkin with the following statements:

Changing the 5-year exclusivity period for traditional small-molecule drugs or the 12-year exclusivity for biologics is unlikely, Brian Malkin, drug industry attorney and partner with Frommer Lawrence & Haug in Washington, told MedPage Today in an interview.

"It's an election year; maybe they're trying to position themselves for the future," Malkin said of Thursday's GPhA report. The savings analysis seemed to be mostly about creating awareness and generating good will for future policy decisions, he said.

For instance, seeking to dissuade a Health Affairs article in November 2011 that stated generic drug usage has increased at a rate that has discouraged the development of new drugs, the GPhA Report highlighted a recent IMS report in April 2012 that found: "...[A]though generic utilization has reached new levels, more new medicines were launched in 2011 that in any other year of the past decade ... since the implementation of Hatch-Waxman, there has been a multiple-fold increase in the innovation of new medicines." The GPhA Report observed: "By creating a fair balance between innovation of new medicines and accessibility to lower cost generic medicines, federal law has established a win-win for providers and American consumers."

Continue reading "Malkin Quoted in MedPage Today Article Regarding New GPhA Study Highlighting Generic Drug Successes and Hopes for Developing a Generic Biological Market" »

August 2, 2012

ACI's FDA Boot Camp in Boston on September 20-21, 2012

Thumbnail image for aci_header_banner.gifOver the past 8 years, thousands of your fellow legal professionals - from Associates to Partners to GCs have relied on ACI's FDA Boot Camp Conference to provide them with both a comprehensive overview of the basics of FDA law and current information on the status of regulatory law in the pharmaceutical, biotechnology, and medical device industries. We hope that this time you will be able to join your peers as this unique event returns to Boston in September.

Learn FDA regulatory basics from the experts--a veritable Who's Who of the FDA Regulatory Bar--and save the calls to regulatory counsel for the really complicated questions. Come, hear, and learn from a stellar faculty of the nation's leading food and drug lawyers, who will explain:

• The application and approval processes for drugs, biologics, and devices
• The regulatory balance between brand name and generic products
• The complexities of the patent and IP landscape, including Hatch-Waxman, Orange Book, 180-day exclusivity, 30-month stay, Paragraph IV, NDA, ANDA and 505(b)(2)
• The pivotal role of labeling in the drug and biologics approval process
• The importance of cGMPs to the post-approval regulatory process
• Advertising and Promotion, DTC Advertising, & Off-Label
• The protocols of adverse events monitoring, pharmacovigilance, and REMS
• Non-patent exclusivity, bioequivalency, and Follow-On Biologics
• Recalls, product withdrawals, and FDA oversight authority

Investing just two days at this event will allow you to round out
your FDA regulatory knowledge and enhance your practice

Save the phone calls to your colleagues or other regulatory counsel for the truly complicated issues; attend ACI's FDA Boot Camp to boost your regulatory IQ
Seating at this event is extremely limited and previous versions of this event SOLD OUT.

FDA Lawyers Blog readers are entitled to a discount when referencing the code: FLB 200

1-888-224-2480 or going online to