FDA Lawyers Blog

FDA Lawyers Blog is pleased to announce that FLH Partner Brian J. Malkin was quoted in an FDAnews article by David Pittman on June 20 commenting on biosimilars and the increasing innovator biological - generic drug pair-ups that have been occurring. Pittman's article focused on the latest Dr. Reddy's - Merck KGaA ("Merck") partnership that reportedly will focus on oncological, monoclonal antibodies. The plan calls for Dr. Reddy's to conduct early-phase research and development with Merck handling the later-phase clinical trials and scale-up manufacturing. In addition, Merck will commercialize the products in most parts of the world, paying Dr. Reddy's royalties, but in the United States, the companies will commercialize the products together on a profit-sharing arrangement.

Malkin was quoted as saying that the generic-biosimilar partnerships are becoming increasingly popular because they help split, the cost, risk, and difficulty in developing biosimilar products. He also explained that the partnerships make sense, because innovator companies are good and developing new products and marketing them, while generic companies are good at deformulating innovative products and finding ways to manufacture them at a lower cost. The partnerships further help to mitigate the inherent weaknesses with each party: innovators are not accustomed to many of the analytical techniques that FDA has said that it will require to demonstrate similarity between innovator biologics and the biosimilar counterparts, and generic companies are not accustomed to marketing their products (for the most part) or formulating biological products, which are much more resource intensive.

Written by Brian Malkin

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Malkin's observations were echoed by statements made by Merck in other arenas, with Merck executive board member Stefan Oschmann saying, "Sharing know-how, risks and rewards is the right approach to enter the emergent biosimilars market and will be a win-win for both parties." According to Merck, it had already factored the investments needed for this collaboration into its profit outlook.

Malkin will be speaking at two upcoming conferences featuring biosimilars next month, first in the Washington, D.C. Area on July 12 with Q1 Productions' Regulatory Clearance & Commercialization of Generic Drugs & Biosimilars Conference and then in Boston on July 17 with the American Conference Institute's Clinical Trials Conference. Malkin's presentations will take advantage of his extensive knowledge of this developing field, fueled by his observation in recent meetings such as the Biotechnology Industry Organization's International Convention, where Malkin attended events featuring key FDA decision makers Janet Woodcock, M.D., Director of the Center for Drug Evaluation and Research, and Karen Midthun, M.D., Director for the Center for Biologics Evaluation and Research identifying key issues in their respective center and speaking about the future of biosimilars, as reported here. These events will be some of the first events to follow the eagerly-anticipated Supreme Court decision regarding the constitutionality of the Affordable Care Act, which possibly threatened the immediate future of biosimilars, if the Act is entirely overturned, as some has speculated.

On June 15, supplemental briefing was completed in Association for Molecular Pathology v. Myriad Genetics, Inc. at the Federal Circuit. The parties had been Ordered to file simultaneous briefs addressing the question: "What is the applicability of the Supreme Court's decision in Mayo [v. Prometheus] to Myriad's isolated DNA claims and to method claim 20 of the '282 patent [U.S. Patent No. 5,747,282]?" In addition, the Federal Circuit invited amicus briefs. As many as seventy organizations and individuals answered this invitation, as well as the United States (who received an express invitation). Oral argument for this appeal is scheduled for Friday, July 20, 2012.

This case considers a fundamental issue, namely: What subject matter is eligible for patent protection? This is a threshold question of patentability, previously reported here, which the United States Supreme Court recently considered in Mayo Collaborative Services v. Prometheus Laboratories, Inc. After deciding Prometheus, the Supreme Court vacated the Federal Circuit's previous decision in Myriad and set this present appeal in motion by remanding the case to the Federal Circuit for reconsideration in light of Prometheus. As demonstrated by their briefing, however, both the Plaintiffs and Myriad have very different takes on what Prometheus stands for--and what subject matter is patentable.

Written by Richard F. Kurz

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The Plaintiffs argue that claiming isolated DNA does no more than to patent laws of nature and products of nature; in other words, the correlation between the patented DNA and the BRCA proteins it encodes. Plaintiffs assert that the product is the DNA itself and "another entity cannot invent a DNA molecule that encodes for the same protein and embodies a person's BRCA1 and BRCA2 genetic information" because Myriad's patents stand in the way. Thus, Plaintiffs state, "[a]s a consequence, no other laboratory in the U.S. has been able to provide clinical testing of these genes . . . ."

The founder of an online pharmacy was recently arrested for allegedly selling counterfeit prescription drugs. Specifically, the United States government has charged Andrew Strempler ("Strempler"), the founder of Mediplan Health Consulting, Inc.--also known as RxNorth.com ("RxNorth")--with one count of conspiracy to commit mail fraud and wire fraud, as well as two counts of mail fraud. A grand jury returned an indictment against Strempler for these offenses in June 2011, but because Strempler was deemed a flight risk, the indictment was sealed until his arrest.

In support of the charges, the indictment alleges that Strempler falsely claimed that RxNorth was selling safe prescription drugs that complied with the rules of United States regulatory authorities. These claims were allegedly made through RxNorth's website and brochures. The indictment alleges that contrary to these representations, Strempler and his co-conspirators obtained the prescription drugs from various countries without ensuring the drugs' safety or authenticity. More specifically, Strempler is alleged to have operated a facility in the Bahamas, where the drugs were shipped. The orders were then allegedly filled in the Bahamas, and given labels stating that they had been filled by RxNorth in Canada. Further, the drugs allegedly were not sold in accordance with FDA regulations, because they were allegedly counterfeit, misbranded, and not FDA-approved. Additionally, the indictment alleges that RxNorth falsely boasted that it was using the "best equipped" laboratory to test its drugs for safety and authenticity even though RxNorth actually only had one piece of equipment that was capable of limited testing.

Written by Jonathan Herstoff

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The indictment further claims that the FDA previously wrote a letter to Strempler in 2001, warning him that it would be illegal to sell drugs that were not approved by the FDA. This allegation, if proven true, will likely be used to show that Strempler knowingly violated federal law. If convicted of the charges, Strempler faces up to twenty years in prison. Additionally, the government seeks forfeiture of the proceeds that Strempler obtained from his allegedly unlawful conduct. The government estimates that Strempler's proceeds have been at least $95 million. This criminal case underscores the federal government's commitment to ensuring that only genuine, FDA-approved prescription drugs are sold in the United States.

In a June 11, 2012 letter, Representative Elijah Cummings of Maryland and Senator John Rockefeller of West Virginia summarized growing concerns about the "gray market" for prescription pharmaceuticals. The pharmaceutical gray market consists of the sale of prescription drugs through distribution channels that, although legal, are unofficial and generally not intended by the products' original manufacturers. The recipients of the letter included Senators Tom Harkin and Michael Enzi as well as Representatives Fred Upton and Henry Waxman. All four Congressmen are working on legislation that would reauthorize the FDA's user-fee programs. That same legislation also addresses pharmaceutical supply chain security, which was the focus of the June 11 letter. It provided the four Congressmen with information obtained from a recent investigation, launched by Representative Cummings and later joined by Senators Rockefeller and Harkin, into the pharmaceutical gray market and its impact on the cost and safety of high-demand but short-supply drugs.

Representative Cummings began his investigation in October 2011 in response to claims by hospitals and health care organizations that some pharmaceutical companies were taking advantage of drug shortages. "Hospitals and patient groups reported numerous examples in which patient care was compromised because hospitals could not obtain adequate supplies [at reasonable prices] of ... [critical] drugs through their normal distribution networks." The investigation initially consisted of information request letters sent by Representative Cummings to five companies that marketed drugs to hospitals. He sought information about the cost and source "of five injectable drugs that were at the time facing national shortages, according to FDA." The study later expanded to include information requests from more than 50 prescription drug manufacturers, distributors, and pharmacies. At least one company refused to disclose its source and price information voluntarily.

Written by Dario A. Machleidt

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The investigation uncovered substantial evidence that many pharmaceutical companies engaged in questionable practices with respect to drugs in short supply. Rather than travel from manufacturer to distributor and then to dispenser, which is the intended distribution chain for prescription pharmaceuticals, short-supply drugs move through much longer gray market distribution channels. Such channels consist of numerous companies that purchase pharmaceuticals and then resell them at inflated prices. This process can happen several times, and on each occasion, the price of the pharmaceuticals increases. "The markups ... bear little or no relation to the companies' cost of purchasing, shipping, or storing the drugs."

Senate Update: On June 26, the Senate Okayed the reconciled user-fee reauthorization bill that had passed the House last week. Again, there was significant bipartisan support for the legislation, which bill passed by a 92-4 margin. All that remains is President Barack Obama's signature, which looks certain to occur before the July 4 goal that Congress had set for the passage of this legislation. While the President's signature will finalize a bill that has been over a year in the making, Thursday's Supreme Court ruling on the constitutionality of the Patient Protection and Affordable Care Act could have an immediate effect on the user fee bill. Most notably, if the Supreme Court strikes the entire healthcare bill, the status of the biosimilar approval pathway would be in question. This, in turn, could lead to some questions about the $128 million dollars the biosimilars companies are scheduled to pay FDA over the next five years.

On June 20, the House passed a reconciled user-fee reauthorization bill by a more-than-two-thirds-voice vote. Earlier in the week, members from the House and Senate ironed out the details of a reconciled user-fee reauthorization bill for FDA. The House passed its version, the Food and Drug Administration Reform Act (H.R. 5651), earlier this month (last discussed here), and the Senate approved its version (S. 3187) in late May (last discussed here). Both versions contained near identical reauthorized the user fee programs for brand-name drugs and medical devices and created new user-fee programs for biosimilars and generic drugs. There were, however, a number of differences that had to be addressed.

Written by Scot B. Pittman

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Among the casualties from the reconciled version was an effort to impose stricter controls for potentially abusive prescription drugs. Congress rejected the Senate's proposal that would have: (1) required patients seeking refills for hydrocodone-combination products to obtain new prescriptions; (2) required a higher level of security for transportation and storage of the drugs; and (3) increased penalties for misusing the drugs. Pharmacists and drug stores opposed these measures, claiming they would make it more difficult from those in pain to get access to their medications and that pharmacies would face expensive administrative obligations under the proposal.

On June 19, FDA Center Directors Karen Midthun, M.D., Director of the Center for Biologics Evaluation and Research ("CBER"), and Janet Woodcock, M.D., Director of the Center for Drug Evaluation and Research ("CDER"), provided a snapshot of each of the respective Center's hot issues for the coming year. Midthun began, noting how CBER's priorities continue to focus on development of vaccines for anticipated disease areas, such as influenza and the possibility of pandemic influenza, such as H1N1, which requires increasing international collaboration with the World Health Organization ("WHO") and the European Medicines Agency ("EMA"). In addition, CBER has worked on the increasing interest in the development of in-home diagnostic test kits, such as a kit for Human Immunodeficiency Virus ("HIV").

Woodcock provided the bulk of the Townhall news, including expected priorities generated by the anticipated new user fees for generic drugs and biosimilars, as well as the Prescription Drug User Fee Act V ("PDUFA V"), which will undoubtedly usher in additional new program priorities. Some issues CDER anticipates in fiscal year 2012-2013 include drug shortages, drug standards/IT, quality management and "lean" pilots (achieving an additional 25% efficiency already), pharmacy compounding, and positron emissions scanning. Interestingly, the new user fees create their own new priorities for creating systems to charge and collect the anticipated user fees, which must be enacted by October 1, because CDER needs the fees, particularly for generic drugs, to begin to tackle the increasing backlog.

Written by Brian Malkin

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Some of the PDUFA V enhancements expected are increased communication between FDA and sponsors during the product review cycles, including additional mid-cycle feedback and late cycle meetings and modifications to the PDUFA clock, meta-analyses methods, biomarkers, a standardized benefit/risk format, use of patient-reported outcomes, additional support for orphan drugs, standardized Risk Evaluation and Mitigation Strategies ("REMS"), using Sentinel to evaluate drug safety, and mandated electronic submissions. Some potential PDUFA V enhancements (not yet passed) include enhanced use of accelerated approval and new procedures for "breakthrough therapies"--both ideas FDA supports.

On June 11, the U.S. Supreme Court agreed to address the issue of whether investors must prove that alleged misrepresentations had a material effect on stock price in order to pursue a class-action stock-fraud suit. Amgen, Inc. ("Amgen") petitioned the Supreme Court for a writ of certiorari addressing the decision from the Court of Appeals for the Ninth Circuit. The Ninth Circuit held that shareholders did not need to show the materiality of alleged misstatements prior to receiving class certification. The Ninth Circuit explained that plaintiffs "need only allege materiality with sufficient plausibility" to be awarded class certification. Amgen's appeal is supported by the U.S. Chamber of Commerce, former SEC commissioners, and the pharmaceutical industry's trade group.

In 1988, the Supreme Court held in Basic v. Levenson that a class only needs to demonstrate an efficient market and alleged public misstatements in order to be certified as a class based on the fraud-on-the-market presumption. However, since that decision, there has been a split among the Circuits as to whether shareholders have to show materiality of the misstatements in order to get class certification. The Second and Fifth Circuits require proof of materiality for class certification and allow defendants to rebut such evidence. The Third Circuit does not require proof of materiality prior to class certification, but, allows defendants to present evidence disproving the materiality of any alleged misrepresentation. The Seventh and Ninth Circuits require no proof of materiality for class certification and defendants cannot present any evidence rebutting the materiality of any alleged misrepresentations.

Written by Erin A. Lawrence

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This suit was brought by Connecticut pension funds on behalf of purchasers of Amgen stock (collectively, "plaintiffs"). Plaintiffs allege that Amgen down-played safety concerns about Aranesp and Epogen--two drugs used to treat anemia--which led to inflated share prices for Amgen stock. Amgen is seeking to overturn the Ninth Circuit's decision that certified the lawsuit as a class action. Class certification confers a substantial benefit to plaintiffs in settlement negotiations because of the substantial risk that defendants take by litigating a class action trial. Amgen argues that allowing class certification in a case such as theirs would lead to settlement of meritless cases. Amgen asserts that plaintiffs in this case cannot show that the alleged misrepresentations had a material effect on the price of Amgen shares. Amgen further asserts that market had readily available access to the drugs' safety information and therefore, adjusted itself accordingly.

Plaintiffs allege that the misrepresentations took place from April 2004 through May 10, 2007. Plaintiffs assert that Amgen's stock price was inflated because Amgen hid concerns that Aranesp and Epogen exacerbated tumor growth in clinical trials. Amgen's shares dropped more than 9% on May 10, 2007 when FDA's expressed concern about these drugs and recommended new limits on patient use. According to plaintiffs, Amgen repeatedly reassured inventors of the safety of Aranesp and Epogen despite this negative clinical trial data. Plaintiffs do not dispute that they need to show the materiality of Amgen's statements, however, they assert that issue should be left for trial, not a decision made prior to class certification. The Supreme Court will hear oral arguments in October 2012.

On June 12, Rite Aid and several pharmacies (hereafter "Rite Aid") filed suit against Wyeth, Inc. ("Wyeth") and Teva Pharmaceuticals USA, Inc. ("Teva") in the United States District Court for the District of New Jersey, alleging that Wyeth and Teva entered into an unlawful agreement to delay Teva's launch of extended release venlafaxine (reference listed drug Effexor XR®) and that Wyeth has unlawfully monopolized the market for extended release venlafaxine. The case is Rite Aid Corp. et al. v. Wyeth, Inc. et al., No. 3:12-cv-03523.

Rite Aid claims that Wyeth entered into an unlawful conspiracy with Teva whereby Teva agreed not to market its generic version of Effexor XR® in exchange for Wyeth's promise not to compete with Teva during Teva's period of generic exclusivity. Due to this conduct, Rite Aid alleges that generic competition was delayed for approximately two years, resulting in significantly higher prices than there would have been if competition had not been blocked. This alleged conduct, according to Rite Aid, constitutes an agreement in restraint of trade in violation of Section 1 of the Sherman Act.

Written by Jonathan Herstoff

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In addition, according to the complaint, Wyeth fraudulently procured patents relating to extended release venlafaxine. This alleged fraud forms the basis for Rite Aid's claims of monopolization under Section 2 of the Sherman Act. In support of its allegations, Rite Aid claims that Wyeth made a series of nondisclosures and misrepresentations to the Patent and Trademark Office ("PTO") that amounted to fraud. For example, Rite Aid alleges that after certain broad claims were rejected and Wyeth agreed to narrow them to secure a notice of allowance, Wyeth abandoned the application, despite the allowance over the narrower claims. Then, according to Rite Aid, Wyeth filed a continuation-in-part patent application containing claims nearly identical to the broad claims that had been rejected earlier. A different examiner was assigned to this new application. According to Rite Aid, Wyeth did not disclose the earlier rejection to the PTO and was able to secure the allowance of the broad (previously rejected) method of use claims.

FLH Partners Sandra Kuzmich, Ph.D., Brian J. Malkin, David Herman, Of Counsel Deena Levy Weinhouse, Associates Kathleen N. Ehrhard, Ph.D., Ami E. Simunovich, Pharm.D., R.Ph., and Scientific Advisors Ali Berkin, Ph.D. and Russell A. Garman, Ph.D. will join the world's leading biotechnology companies at the Annual BIO International Convention this year, to be held in Boston, Massachusetts from June 18-21. The FLH team will be located at Booth # 2705, where they will feature information about Life Sciences at FLH, including a number of articles and presentations on biotechnology authored by FLH, and will answer questions about FLH's Life Science practice and how it helps to maximize the value of our clients' assets.

On June 18-21, FLH Partners Sandra Kuzmich, Ph.D., Brian J. Malkin, David Herman, Of Counsel Deena Levy Weinhouse, Associates Kathleen N. Ehrhard, Ph.D., Ami E. Simunovich, Pharm.D., R.Ph., and Scientific Advisors Ali Berkin, Ph.D. and Russell A. Garman, Ph.D. will host a booth at the Annual BIO International Convention in Boston, Massachusetts. FLH's booth is located at Booth # 2705, which will feature information about FLH's Life Sciences Practice, as well as a number of articles and presentations on biotechnology authored by FLH. Come meet our team, who will answer questions about what sets FLH's Life Science Practice apart with its multidisciplinary, integrated approach to addressing legal issues and business challenges involved in maximizing the value of our clients' assets. Our size, structure, and technical capabilities allow us to seamlessly integrate our various specialties, affording our clients a unique mechanism by which to create, expand, and protect their intellectual property and more.

On June 7, the Federal Circuit in In re Bill of Lading Transmission & Processing System Patent Litigation clarified the standards necessary to plead a claim of patent infringement. Notably, the Federal Circuit (O'Malley, J.) discussed the differences between stating a claim for direct patent infringement versus indirect patent infringement (i.e., induced infringement or contributory infringement). The case involves a patent directed to "a method in which documents are scanned on board vehicles for use by dispatchers in preparing manifests dictating which shipments should be consolidated and shipped on which trucks heading to which location." Slip op. at 28. The District Court dismissed the plaintiff's complaints under Rule 12(b)(6). Among other things, the District Court found that the complaints were based upon conclusory allegations of direct infringement that were based upon unreasonable inferences. The plaintiff then appealed to the Federal Circuit.

Regarding direct infringement, the Federal Circuit concluded that the District Court had improperly required too high of a standard to meet the pleading requirements for direct infringement. Specifically, the Federal Circuit pointed to Form 18 in the Appendix of Forms to the Federal Rules of Civil Procedure, which lays out a sample complaint for direct patent infringement. Form 18 requires: (1) an allegation of jurisdiction; (2) a statement that the plaintiff owns the patent; (3) a statement that the defendant has been infringing the patent by making, selling, and using the device embodying the patent; (4) a statement that the plaintiff has given the defendant notice of its infringement; and (5) a demand for an injunction and damages. The Federal Circuit explained that under Rule 84, the forms are deemed sufficient. Accordingly, the Federal Circuit concluded, in the event of a conflict between the forms and the Supreme Court's pleading standards set forth in Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007) and Ashcroft v. Iqbal, 556 U.S. 662 (2009), the forms control. Therefore, for claims of direct patent infringement, the question of whether a complaint contains sufficient specificity must be measured by the specificity required by Form 18.

Written by Jonathan Herstoff

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Regarding indirect infringement, however, the Federal Circuit found that Form 18 is of no assistance. This is because the complaint in Form 18 only involves a claim of direct infringement. Accordingly, for claims of induced and contributory infringement, the standards outlined in Twombly and Iqbal apply. Therefore, the Federal Circuit explained, to state a claim for contributory infringement, the plaintiff must, "among other things, plead facts that allow an inference that the components sold or offered for sale have no substantial non-infringing uses." Slip op. at 21. More particularly, the Federal Circuit found it insufficient simply to set forth an infringing use and then baldly conclude that there is no other substantial non-infringing use. As for induced infringement, the Federal Circuit concluded that a complaint must contain facts plausibly showing that the accused infringer specifically intended its customers to infringe the patent and knew that the direct infringer's acts constituted infringement.

On May 22, the United States District Court for the Central District of California granted
a prevailing patent infringement plaintiff's motion for attorneys' fees under Section 285 of the Patent Act. Jake Lee v. Mike's Novelties, Inc., et al., LA CV10-02225, Order Granting Motion for Attorney Fees and Motion for Enhanced Damages, May 22, 2012, ECF No. 197. The Court concluded that an award of attorneys' fees was appropriate, in part because the defendants had engaged in bad faith litigation tactics. These tactics included, among other things, bad faith settlement offers, unreasonable delay tactics during a deposition, and threats to report the plaintiff's attorneys to various state bars. To the extent patent challenges continue to be part of the landscape for applicants filing generic drug applications (Abbreviated New Drug Applications or "ANDAs"), new drug applications under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act ("505(b)(2) NDAs"), and in the future biosimilar applications, litigators involved in these challenges should consider best practices to avoid the payment of attorney fees for such behavior.

Regarding the bad faith settlement offers, the court found that counsel for the defendants had repeatedly sent intimidating written communications to the plaintiff's counsel demanding that the plaintiff dismiss his claims and pay the defendants their attorney's fees. In one communication, the plaintiff was warned that he was "in a hole that is getting deeper every day," and that he should "settle this case and limit [his] exposure to a very bad result" in light of the Court's summary judgment and claim construction rulings. The Court found that these communications were made in bad faith. In particular, the Court pointed to the fact that the plaintiff had prevailed on its claim construction arguments, and further pointed to the intimidating nature of the communications. Accordingly, the Court found that these communications weighed in favor of an award of attorneys' fees.

Written by Jonathan Herstoff

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Additionally, the Court considered the defendants' delay tactics during one of the depositions. In particular, when the plaintiff's counsel attempted to take the deposition of one of the defendants in the plaintiff's presence, the deponent refused to allow the deposition to proceed in the plaintiff's presence. The deposition did not continue until the Court ordered the deposition to proceed, resulting in a two-hour delay. Although the Court found that this conduct offered "modest support" for an award of attorneys' fees, it found that this behavior alone would be insufficient to justify such an award.

On May 30, AstraZeneca Pharmaceuticals LP ("AstraZeneca") reached an agreement to a settlement with a class of indirect purchasers in an antitrust action involving the drug Toprol-XL® (metoprolol succinate) in Delaware. The class of indirect purchasers allege that AstraZeneca used frivolous patent litigation as a method of delaying generic competition for Toprol-XL®.

In an order signed by Chief U.S. District Court Judge Gregory M. Sleet, the case was stayed following a joint notice highlighting that the parties had reached an agreement in principle to settle all claims. Mark S. Merado, the lead plaintiff in the case, filed the suit in February of 2006, alleging that AstraZeneca created a monopoly or was attempting to create a monopoly for Toprol-XL® and was thus in violation of both the Sherman and Clayton Acts.

Written by Kenneth J. Szeto

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Merado alleged that AstraZeneca fraudulently obtained U.S. Patent Nos. 5,001,161 ("the '161 patent") and 5,081,154 ("the '154 patent") and filed sham patent infringement suits against generic competitors to delay the approval and market entry of generic metoprolol succinate. "Defendants knew that under the Hatch-Waxman Act, the mere filing of patent litigation--even groundless suits based on invalid or unenforceable underlying patent--would automatically prevent the FDA, for up to 30 months, from granting generic competitors final approval," the complaint said. The suit asked the court to find the '161 and '154 patents invalid and to order AstraZeneca to provide restitution for the plaintiffs by disgorging its unjust enrichment.

On June 5, SoloHealth announced that FDA approved its next-generation SoloHealth Station, a self-service health care device which strives to assist people with both education and awareness about their health. SoloHealth, an Atlanta-based company, has worked to empower consumers through the use of technology to achieve a healthier, and consequently better, America. With the recent FDA approval and an aggressive rollout plan for 2012, the SoloHealth Station is taking the lead in using self-service technology to develop a healthier America.

Just prior to receiving the inaugural Intel Innovation Award, CEO and Founder of SoloHealth, Bart Foster, described the SoloHealth Station as a kiosk equipped with both the "functionality and technology to drive consumer education, awareness, and ultimately action." SoloHealth makes clear that the kiosk will not replace an examination by a medical professional. Essentially, the SoloHealth Station will provide consumers with an initial health screening and encourage them to visit a health care provider for a follow-up examination.

The SoloHealth Station offers a highly personalized, targeted, and interactive opportunity for consumers by employing a touch user interface and interactive video to guide consumers through the simple health tests. It will allow consumers to screen their vision, blood pressure, weight, and body mass index in less than seven minutes. In addition, the SoloHealth Station will provide a symptom checker as well as an overall health assessment. These services are provided free of charge.

On May 31, the National Association of Chain Drug Stores ("NACDS") posted a press release announcing that NACDS, the American Pharmacists Association ("APhA"), and the National Community Pharmacists Organization ("NCPA") had filed a joint letter dated May 25, 2012 with FDA to help facilitate dispensing biosimilar products via pharmacies. The letter was filed in FDA's Docket No. FDA-2011-D-0618, which related to a one-day public hearing on May 11, 2012, where FDA heard comments on its three draft guidances released on May 9 and posted in The Federal Register several days later. We previously reported on the three guidances here.

In the letter, the pharmacist groups wrote:

Pharmacists will be greatly impacted by the decisions made on how the biosimilar pathway is implemented. Pharmacists are the most accessible healthcare professionals and recommending generic alternatives is a standard pharmacy practice. Allowing pharmacists to perform fully within their scope of practice by permitting automatic substitution of cost-effective biologic and specialty medications increases availability, thereby greatly benefitting the entire health care system and the patients it serves.

Written by Brian Malkin

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As part of their proposal, the pharmacist groups requested FDA to consider:

• Biosimilar products should maintain the same individual nonproprietary names ("INNs") as their reference counterparts to help prevent confusion with no additional suffixes, as has been done for human growth hormone and insulin. For purposes of tracking products for adverse events or quality issues, systems should be retooled to utilize National Drug Code ("NDC")-type numbers.

Last Wednesday, the House of Representatives passed the Food and Drug Administration Reform Act (H.R. 5651), which reauthorizes the user fee programs for brand-name drugs and medical devices and creates new user-fee programs for biosimilars and generic drugs. Like its counterpart in the Senate (previously discussed here), the Bill has significant bipartisan support, which is evidenced by the 387-5 vote.

The user fee provisions of the House version are almost identical to those on the Senate Version. Drug and devices makers will have to pay FDA $6.4 billion over five years to help finance the evaluation and review of their products. Again, brand-name drug companies will pay $4.1 billion, generic drug companies will pay $1.6 billion, device makers will pay $609 million, and biotechnology companies will pay $128 million. In exchange for the user fees, FDA will be required to meet certain performance goals throughout the five years. These performance goals are intended to decrease the average review time for FDA approvals of drugs, devices, and biosimilars.

Written by Scot B. Pittman

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The House's Bill also has provisions outside the user-fee arena. Of particular importance, the bill:

• Provides for increased oversight of medical devices by pushing FDA to institute an electronic monitoring system and requiring post-market studies of certain medical devices.


• Removes the requirement that every U.S. drug manufacturing facility be inspected every two years and increases FDA's discretion to inspect more foreign manufacturers.


• Requires mandatory reporting of potential drug shortages.


• Increases the maximum penalty for drug counterfeiting from 3 to 20 years in prison.


• Allows FDA to relax the clinical trial standards for new medicines that address life-threatening diseases.


• Requires that FDA provide reasons for denying medical implants within thirty days of issuing a rejection.

On May 17, Osmotica Pharmaceutical Corp. ("Osmotica") filed a somewhat unusual citizen petition requesting that FDA refuse to approve Sun Pharma Global Inc.'s ("Sun's") 225 mg Venlafaxine Hydrocholoride Extended-Release Tablets because of the size of Sun's tablets.

Wyeth Pharmaceuticals Inc. ("Wyeth") (now Pfizer Inc. ("Pfizer") first obtained FDA approval for Venlafaxine Hydrochloride, an antidepressant sold under the trade name Effexor®, in 1993. Wyeth's patent for the compound expired in 2008, although it still holds Orange Book-listed patents for methods of using extended release venlafaxine. In 1997, FDA approved Wyeth's Extended-Release Capsules, 37.5 mg, 75 mg, 100 mg, and 150 mg, under NDA No. 020699. As an aside, Wyeth's decision to list the method-of-use patents in the Orange Book and to assert them against generic competition has led to allegations of antitrust violations.

Written by Christopher Gosselin

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Osmotica's 505(b)(2) application (NDA No. 022104) for Venlafaxine HCl Extended Release Tablets, 37.5 mg, 75 mg, 150 mg, and 225 mg, received FDA approval in 2008, referencing Wyeht's Effexor XR® capsules. Later the same year, FDA granted Osmotica's citizen petition requesting that FDA require ANDA applicants, specifically Sun, to submit new ANDAs and conduct new bioequivalence studies using Osmotica's tablets, rather than Wyeth's capsules, as the reference listed drug ("RLD"), because it is the most similar pharmaceutical equivalent (i.e., an extended-release tablet). Sun, an Indian Corporation, subsequently obtained FDA approval for tablets on three of Ostmotica's four dosage strengths, 37.5 mg, 75 mg, and 150 mg. Sun's Venlafaxine HCl Extended Release Tablets have an AB-therapeutic equivalence rating to Osmotica's product (i.e., a generic substitute product).

The European Medicines Agency ("EMA") has launched a new website that makes suspected side effect reports for medicines authorized in the European Economic Area ("EEA") publically available. The data comes from the medicines safety database EudraVigilance, and the new website is part of the EMA's continuing efforts to ensure EMA's regulatory processes are transparent and open and is in part due to implementation of the EudraVigilance access policy. The launch also highlights the importance of side effect reporting and pharmacovigilance in safeguarding public health within the European Union.

The data covers approximately 650 medicines and active substances authorized via the centralized procedure and it is hoped that the database will be expanded to cover nationally authorized products by the end of the year. The aggregated data can be viewed by age group, sex, type of suspected side effect, and by outcome. This new EMA website makes the information both readily accessible and readable to lay people, who are not familiar with the usual detailed reports provided to health care professionals. The EMA explains in its press release that a side effect (also known as an adverse drug reaction) includes side effects arising from use of a medicine within the terms of its marketing authorization, as well as from its use outside the approved indications, including overdose, misuse, abuse, and medication errors, and those associated with occupational exposure.

Written by Howard E. Rosenberg, Ph.D.

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Most importantly the EMA explains that information on the website relates to suspected side effects, i.e., medical events that have been observed following the use of a medicine, but which are not necessarily related to or caused by the medicine. As a consequence, information on suspected side effects should not necessarily be interpreted as meaning that the medicine or the active substance causes the observed effect or is unsafe to use. A detailed evaluation and scientific assessment of all available data is required for correct conclusions to be drawn as to the benefits and risks of any medicine. It is expected that the reporting of side effects is normally to be carried out by healthcare professionals, but patients are able to report suspected side effects directly through various methods such as online patient reporting forms hosted by national medicines regulatory authorities or by telephone.