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

July 30, 2012

Forest Laboratories/Almirall's Tudorza™ Pressair™ COPD Drug Approved by FDA

On July 23, 2012, FDA approved Tudorza™ Pressair™ (aclidinium bromide inhalation powder) for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease ("COPD"). COPD, which is most often caused by smoking, includes chronic bronchitis and emphysema, and affects close to 24 million people in the United States. While quitting smoking is the best option for reducing the progression of COPD, the damage caused by the disease is irreversible, and there is currently no cure.

Chronic bronchitis is a chronic inflammation and tightening of the airways, characterized by a phlegm-producing or mucus-producing cough which lasts for at least three months in at least two consecutive years. Emphysema is a long-term lung disease where the walls of the air sacs become damaged, preventing a person from fully exhaling used air, and from inhaling enough fresh air. Individuals with COPD suffer from difficulty breathing, shortness of breath, wheezing, reductions in energy, as well as other symptoms. Many individuals dismiss these symptoms as age-related or as nothing more than a "smoker's cough." Consequently, only about one half of COPD cases are actually diagnosed.

Tudorza™ Pressair™ is a non-steroidal, long-term-maintenance treatment that loosens the muscles around the lungs in order to open constricted airways and to increase airflow in COPD patients. Tudorza™ Pressair™ is a long-acting muscarinic antagonist ("LAMA," or "anticholinergic"), which blocks the muscarinic receptors in the airways, leading to airway relaxation and improved lung function. Since 2004, the Pfizer Inc./Boehringer Ingelheim Spiriva® Handihaler® has been the only approved LAMA available to COPD patients.

Continue reading "Forest Laboratories/Almirall's Tudorza™ Pressair™ COPD Drug Approved by FDA" »

July 27, 2012

FLH Partner Brian J. Malkin Quoted in FDAnews Article on Jazz Citizen Petition Regarding Generic Xyrem®

On July 26, FLH Partner Brian J. Malkin was interviewed and quoted in FDAnews' article: "Jazz Petitions FDA, Alleges Agency Wrongly Accepted Xyrem ANDA" available here (subscription required for full story). Malkin and another FDA attorney, David Rosen, were both quoted in the article to provide some color surrounding Jazz's latest Citizen Petition regarding generic Xyrem® (sodium oxybate):

Despite Jazz's arguments, David Rosen, an attorney at Foley & Lardner, questions whether the FDA actually accepted an incomplete application. The FDA, including the Office of Generic Drugs, is well aware of REMS requirements and wouldn't accept an ANDA application if it was deficient on its face, Rosen told DID, noting there is more than one way to put appropriate controls in place for drugs. "The FDA has been taking [ANDA] filings seriously," he said, adding he is confident the FDA is good at judging completed applications.

And Brian Malkin, an attorney at Frommer Lawrence & Haug, explained that because Jazz's Xyrem REMS is still pending and not yet accepted by the agency, generic filers would typically only be required to include the "same essential elements" of a risk management plan in their ANDA application, a flexible approach that could have been satisfied by Roxane. ANDA filers for companies with approved REMS are held to a different standard, Malkin explained.

As FDA Lawyers Blog previously reported here, Jazz's latest Citizen Petition focuses on FDA's same labeling requirement for generic drugs and argues that risk management programs are included in that same labeling.

Jazz's Xyrem Citizen Petition

While Xyrem® has been designated by FDA as a product that has been deemed to have a Risk Evaluation and Mitigation Strategy ("REMS"), FDA does not list Xyrem® as a product with an approved REMS. To some extent, Xyrem® 's risk management program called the Xyrem® Success Program has been described on its website and in FDA's review package and public documents for Xyrem®.

Continue reading "FLH Partner Brian J. Malkin Quoted in FDAnews Article on Jazz Citizen Petition Regarding Generic Xyrem®" »

July 26, 2012

Corindus Robotic-Assisted Angioplasty System Receives 510(k) Clearance

Written by Douglas Oosterhouse

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On July 25, Corindus Vascular Robotics announced that FDA has granted a 510(k) premarket clearance for its CorPath® 200 System for use in performing percutaneous coronary interventions ("PCI"), otherwise known as angioplasty. David M. Handler, President and CEO of Corindus, calls it "the world's first system designed for robotic assisted PCI procedures." The newly-approved system is designed to assist interventional cardiologists in performing PCI more accurately and with reduced health concerns for surgeons.

PCI procedures are relatively common, but they pose risks to the operating cardiologists. The procedure involves a surgical technique in which blood flow is restored to a blocked coronary artery by inserting a balloon catheter into the artery, inflating it, and then implanting a stent to keep the artery open. While undergoing the procedure, the patients are x-rayed, and the surgeon is also exposed to the radiation. Generally surgeons wear a protective lead apron to minimize exposure to the radiation, but recent data has demonstrated that daily exposure can lead to health risks such as cancer and cataracts. The aprons are often heavy and the procedure can last for several hours. Over time, this can lead to orthopedic problems. Additionally, Corindus points to data published in the American Journal of Cardiology in 2008 showing that nearly 47% of stents are not optimally placed due to difficulties in visualization, measurement, and imprecise stent deployment.

The CorPath® 200 System offers a solution to these problems by robotically-assisting the cardiologist in the controlled placement of coronary guidewires and stent/balloon catheters while the physician resides safely inside lead-lined cockpit. The cockpit protects the cardiologist from radiation exposure and allows the procedure to be done in a seated position in front of monitors which provide an enhanced view of the angiography screen. The system includes a robotic drive and a single-use cassette, which contains the guidewire, balloon, and stent, mounted to an arm on the cathether lab table. The cardiologist controls the robotic drive from the cockpit by using two joysticks and a touch screen monitor, which allow the surgeon to be incredibly precise while minimizing radiation exposure and fatigue. The CorPath PRECISE trial, a study involving 164 patients at nine locations, which served as the basis for the 510(k) application, showed a reduced radiation exposure rate of 95% for physicians. The cockpit is located at the foot of the cathether lab table and the operator can easily switch from a remote procedure to a manual procedure if necessary.

Continue reading "Corindus Robotic-Assisted Angioplasty System Receives 510(k) Clearance" »

July 25, 2012

FLH Partner Malkin Adds Biosimilars to ACI's Clinical Trials Conference in Boston

Thumbnail image for 3699948229_d7732f8df0_o.jpgOn July 17, 2012, FLH Partner Brian J. Malkin joined other experts in the field of clinical trials to discuss methods for ensuring safe and compliant domestic and international clinical trials. New to the ACI's Clinical Trials Conference running for more than seven years was Malkin's presentation "Safely Conducting Biosimilars Clinical Trials: Understanding FDA's Requirements for Biosimilar Clinical Trials". The audience was comprised of many individuals seasoned in traditional clinical trials, who came to the conference in Boston to learn about the newest trends in clinical trials.

Some of the featured government speakers included Karena Cooper, J.S., M.S.W., Acting Associate Director of Policy and Communications and Regulatory Counsel, Office of Scientific Investigations ("OSI"), Center for Drug Evaluation and Research, FDA, and Mary E. Crawley, Assistant U.S. Attorney, Eastern District of Pennsylvania. Other featured speakers included former government enforcers and top in-house counsel from sponsor biopharmaceutical and medical device companies, contract research organizations ("CROs"), hospitals, universities, and research institutions.

Cooper described FDA's new inspection platform, where FDA does not need to inspect a facility to issue a warning letter, and the reorganization of the Office of Compliance. In terms of postmarket studies, sponsors are now provided with milestone timetables where failure to complete a milestone by a certain time will result in a violation. While a sponsor may show "good cause" for failure to meet a milestone, FDA has a very limited high bar, essentially for items completely outside the sponsor's control. Examples where FDA did not find good cause included difficult recruitment, costly studies, or development of data in lieu of the data that the sponsor agreed to provide. Regarding postmarket studies, however, FDA has already issued its first warning letter dated February 17, 2012 that utilized the no-inspection format. In this letter, FDA provided the sponsor with 30 calendar days to respond. FDA's Office of Compliance also has new civil money penalties to enforce its provisions that Cooper said FDA is "actively considering" but has not utilized yet. Cooper also described how FDA is working with the European Medicines Agency ("EMA") for joint and observed inspections, where there is a "robust" confidentiality agreement in place.

Continue reading "FLH Partner Malkin Adds Biosimilars to ACI's Clinical Trials Conference in Boston" »

July 24, 2012

ANDA Risk Management Program Omission Cited by Jazz as Reason to Rescind ANDA Approval in Citizen Petition

Earlier this month, Jazz Pharmaceuticals ("Jazz") submitted a Citizen Petition requesting that the FDA rescind its acceptance of Roxane's abbreviated new drug application ("ANDA") referencing Xyrem®, an oral solution indicated for the treatment of patients with narcolepsy. In its petition, Jazz argues that Roxane's ANDA did not have the same labeling and conditions of use as Xyrem®, because it did not contain a risk management system when it was submitted. Jazz asks that the FDA require Roxane to file a new ANDA, which would result in a new thirty-month stay of the associated New Jersey Hatch-Waxman litigation.

Jazz's Xyrem Citizen Petition

Xyrem® is the sodium salt of gamma-hydoxybutyric acid ("GHB"), a notorious "date-rape" drug. In 2000, Congress passed the Hillory J. Farias and Samantha Reid Date-Rape Drug Prohibition Act, defining GHB as a Schedule I controlled substance but creating an exception for FDA-approved drugs containing GHB. FDA approved Xyrem® in 2002, requiring extraordinary restrictions on the drug product's use under 21 C.F.R. § 314, Subpart H, including a restricted distribution program, an education program, restrictions on the distribution of prescriptions, and a registry system. To meet these demands, Jazz implemented and patented the "Xyrem® Success Program," and listed the patents claiming methods of using its program in FDA's Orange Book.

Jazz claims that Roxane's ANDA did not include a proposed risk management system when it was submitted. Instead, Jazz explains that Roxane submitted a six-page document describing a partial proposed risk management program for generic Xyrem® ten months after its initial ANDA submission and did not submit a full proposal until more than a year after the initial ANDA submission.

Continue reading "ANDA Risk Management Program Omission Cited by Jazz as Reason to Rescind ANDA Approval in Citizen Petition" »

July 23, 2012

Myriad's Re-Argument in the Federal Circuit Still Leaves the Outcome Open

federalcircuit.jpgOn July 20, the United States Court of Appeals for the Federal Circuit heard re-argument in Association for Molecular Pathology et al. v. United States Patent and Trademark Office et al. On the panel were Judges Alan Lourie, William Bryson, and Kimberly Moore. The Federal Circuit decided in 2011 that certain claims to isolated DNA were patent-eligible under 35 U.S.C. § 101, but the United States Supreme Court vacated the Federal Circuit's judgment and remanded for further consideration in light of Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012) ("Prometheus"). Association for Molecular Pathology v. Myriad Genetics, Inc., 132 S. Ct. 1794, 1794 (2012) (granting certiorari, vacating, and remanding). (For a previous discussion on Myriad supplemental briefing for the Federal Circuit see our blog here.)

Myriad Genetics ("Myriad") argued that nothing in Prometheus should change the conclusion that isolated genes are patent-eligible. More specifically, Myriad addressed the Prometheus Court's concern that access to products of nature should not be "preempted." In response to this concern, Myriad explained that nothing in Prometheus altered the Supreme Court's earlier decision in Diamond v. Chakrabarty, 100 S. Ct. 2204 (1980), which held that a genetically-engineered bacterium constituted patentable subject matter, and placed great importance on the fact that the bacterium was human-made. Additionally, Myriad addressed the effect of Prometheus on Claim 20 of U.S. Pat. No. 5,747,282 ("Claim 20"), which recites:

A method for screening potential cancer therapeutics which comprises: growing a transformed eukaryotic host cell containing an altered BRCA1 gene causing cancer in the presence of a compound suspected of being a cancer therapeutic, growing said transformed eukaryotic host cell in the absence of said compound, determining the rate of growth of said host cell in the presence of said compound and the rate of growth of said host cell in the absence of said compound and comparing the growth rate of said host cells, wherein a slower rate of growth of said host cell in the presence of said compound is indicative of a cancer therapeutic.

Myriad argued that unlike the claim in Prometheus, which claimed a method based on a routine idea, Claim 20 applies routine steps to a new composition of matter (i.e., the transformed eukaryotic host cell containing an altered BRCA1 gene).

The Association for Molecular Pathology ("AMP") argued that the breath of the claims at issue is "stunning." It argued that because of this breadth, the claims preempt the use of products of nature, and therefore must therefore are invalid under section 101 as interpreted by Prometheus. Judge Moore was not persuaded by this argument and recited a quote from Prometheus that explained that patent eligibility has never been decided based upon whether a law of nature is "sufficiently narrow." Therefore, Judge Moore said that AMP's preemption argument was "a waste of time and space." Regarding Claim 20, AMP argued that this claim was invalid under Prometheus because it simply recited "putting the stuff all together in the cell and seeing what happens." Especially interesting was AMP's response to a question from Judge Lourie, who inquired whether a method of using penicillin would be patent-eligible. Although the argument was not entirely clear, it appears that AMP was arguing that a method for using penicillin's anti-bacterial properties is "clearly not patentable."

Continue reading "Myriad's Re-Argument in the Federal Circuit Still Leaves the Outcome Open" »

July 20, 2012

Europe Reviews Gene Therapy Favorably for the First Time

genetherapy.jpgThe promise of gene therapy as a commercially-available tool for treating genetic disorders may finally be inching closer to reality. On July 20, 2012 the European Medicines Agency ("EMA") Committee for Medicinal Products for Human Use ("CHMP") took the first step towards making gene therapy treatment a reality by recommending the gene therapy, Glybera® (alipogene tiparvovec), for marketing approval in the European Union ("EU"). Glybera®, which is indicated for the treatment of lipoprotein lipase ("LPL") deficiency, was developed by Netherlands-based, uniQure.

Patients lacking LPL enzymes are unable to break down fats. The CHMP press release states that:

So far, management of patients with the disorder consists of strict reduction of dietary fat to less than 20% of the daily caloric intake. It is very difficult to comply with such a dietary regimen and as a consequence many patients experience life-threatening pancreatitis attacks requiring admission to hospital.
Due to the difficult circumstances faced by individuals suffering from LPL deficiencies that trigger severe or multiple pancreatitis attacks, the CHMP has deemed the treatment benefits afforded by this gene therapy to be worth its risks.

Fundamentally, gene therapy is a method by which exogenous "functioning" or "normal" DNA replaces "abnormal" DNA that is responsible for a particular genetic disorder. Gene therapy was originally touted in the 1970s as a potential way to treat genetic disorders.

Continue reading "Europe Reviews Gene Therapy Favorably for the First Time" »

July 19, 2012

Truvada® Approved for HIV Preventative Use

aidsart.pngOn Monday, July 16, FDA approved the first drug to be used for preventing Human Immunodeficiency Virus ("HIV") infection, in what reporters are calling "a milestone in the 30-year battle against the virus that causes AIDS," a "huge step toward controlling the spread of HIV," and a contributing factor to "the turning point in the AIDS epidemic." Truvada®, a pill owned by Gilead Sciences, is a drug used to treat HIV and Acquired Immunodeficiency Syndrome ("AIDS") since 2004. However, Monday's approval permits Gilead Sciences to market the drug for preventative use, potentially dramatically increasing the number of doctors prescribing the drug for that use. Using Truvada® as a preventative measure could help slow the spread of HIV, which currently infects about 50,000 new Americans per year.

Truvada® is a combination of two anti-HIV medications: Emtriva® (emtricitabine) and Viread® (tenofovir disoproxil fumarate). The two medications are combined into a single pill that is taken once a day with or without food. The drug works by lowering the amount of virus circulating in infected people's blood. Truvada® blocks the activity of the enzyme (HIV-1 reverse transcriptase) the virus needs to replicate and consequently slows down the progression of HIV by limiting its ability to take hold and start an infection.

Written by Elizabeth Zinke

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The drug is approved for use by healthy, uninfected individuals who are at high risk of contracting HIV. Individuals considered "high-risk" include sex workers and people with HIV-positive partners. Additionally, people who engage in high-risk behaviors such as using intravenous drugs fall into the "high-risk" category. To prevent HIV infection, or at least reduce the risk of HIV infection, uninfected individuals at a high-risk of acquiring the virus must take the drug daily before and after exposure. Prevention, however, comes at a steep cost. A Truvada® prescription ranges from about $11,000 to $14,000 annually.

Continue reading "Truvada® Approved for HIV Preventative Use" »

July 18, 2012

Wasson Speaks at FDLI's Inaugural Intellectual Property Throughout the Drug Development Lifecycle Conference in Washington, D.C

FDLILogo.jpgFDA Lawyers Blog is pleased to report that Andrew S. Wasson, Partner, in our New York office was a presenter at the Food and Drug Law Institute's ("FDLI's") "Intellectual Property Throughout the Drug Development Lifecycle: Opportunities and Challenges" Conference in Washington, D.C. on July 17. This Conference addressed intellectual property ("IP") issues important to patent litigators and in-house counsel in the pharmaceutical and generic industries, as well as critical regulatory issues affecting those industries.

The early-morning session began with presentations about The Role of IP During Drug Discovery and Pre-Clinical Drug Development. In this session, the speakers addressed various issues including:

  • Whether and when to publish scientific findings and studies

  • Transactional due diligence and informational sharing concerns regarding intellectual property

  • Differences between patenting process for drugs versus biosimilars

  • AIA alterations and effects on inventorship, prior art, and trade secrecy.

  • The late-morning session covered Brand Development Through IP in the Clinical Testing Phase. The issues in that session addressed:

  • Regulatory considerations for patent listing and labeling

  • Non-traditional IP protection strategies for pharmaceutical companies and their products.

  • Trademark and social media issues on the internet.

The afternoon session kicked off with presentations about Post-Marketing IP Protection and Enforcement. These presentations focused on:

  • FDA and patent exclusivities

  • A generic side perspective of post-marketing IP protection and enforcement

  • The AIA's invalidation procedures

  • Compulsory licensing and the TRIPS Agreement.

The program concluded with a roundtable discussion, which included Wasson, about Third Party IP: Preserving Freedom to Operate ("FTO"). Key issues addressed were:

  • Surveying the landscape

  • How to conduct an FTO search

  • Obtaining competent clearance opinions

  • Overcoming or working around blocking patents

  • Taking advantage of the 271(e)(1) "safe harbor"

  • Off shoring strategies and issues

Wasson spoke on the topic: Third Party IP: Preserving Freedom to Operate. He was joined by Andrea Kamage of Johnson & Johnson and Vincent Capuano of Duane Morris LLP. The group focused on rights required to ensure freedom to operate for third parties. Key issues addressed were:

  • Surveying the landscape

  • Mechanics of Conducting the FTO Search

  • Obtaining competent clearance opinions

  • Overcoming or working around blocking patents

  • Taking advantage of the 271(e)(1) "safe harbor"

  • Off shoring strategies and issues.

Unlike similar conferences frequently attended by patent attorneys, FDLI's conference focused on educating food and drug attorneys about some essential related patent concepts.

July 17, 2012

FDA E-Mail Whistle-Blower Investigation Continues as New Documents Are Revealed

whistle.bmpIn February 2012, FDA Lawyers Blog wrote regarding FDA's secret e-mail monitoring of whistle-blowers in the Center for Devices and Radiological Health ("CDRH"). Now it appears that FDA's surveillance program, which began as an effort to determine whether five FDA scientists were leaking trade secret information, may have been much broader than previously known. According to a New York Times article published on July 15, an FDA contractor inadvertently posted a database containing more than 80,000 surveillance-related documents onto a public website. These documents revealed the extent of the surveillance program that tracked communications between the scientists and Congressional officials, journalists, and others. The surveillance software utilized by FDA allegedly tracked keystrokes, intercepted personal e-mails, and took screen shots of letters being drafted to members of Congress, the Office of the President, and the Office of Special Counsel ("OSC"), an independent federal agency which investigates whistle-blower retaliation claims.

Federal agencies have broad power to monitor employees' computer usage. In fact, FDA computers warn employees when logging on that they have "no reasonable expectation of privacy," and that the Agency may intercept data for any lawful government purposes. However, it is still possible that FDA acted unlawfully when intercepting certain legally protected communications, such as, attorney-client communications, whistle-blower complaints, and workplace grievance filings. The OSC sent a memorandum to all government agencies in June identifying the legal restrictions and guidelines that agencies should consider with regard to monitoring employee communications. Members of Congress have demanded an investigation into the legality of the FDA's program.

Written by Douglas Oosterhouse

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FDA defended the program, saying it restricted surveillance to the five scientists suspected of leaking trade secret information. The Agency established the operation after the Inspector General at the Department of Health and Human Services refused to launch a criminal investigation into the scientists' alleged wrongdoing. FDA officials acknowledge that the operation intercepted communications that the scientists had with Congressional officials, journalists, and others, but FDA maintained that the e-mails "were collected without regard to the identity of the individuals with whom the user may have been corresponding." Additionally, FDA claimed that they did not intend to prevent employees from making these communications, and that individuals outside of the agency were not targets of the operation.

Continue reading "FDA E-Mail Whistle-Blower Investigation Continues as New Documents Are Revealed" »

July 13, 2012

GDUFA and Biosimilars Key Topics at Q1 Productions Regulatory and Commercialization of Generic Drugs & Biosimilars in Alexandria

On July 12-13, Q1 Productions hosted a conference in Alexandria, Virginia: "Regulatory Clearance & Commercialization of Generic Drugs & Biosimilars" to a full house. FLH Partner Brian J. Malkin spoke on "Biobetters and Extending into the Marketplace Beyond Patent Expiration", moderated and commented in a kickoff panel with Marcie McClinitic Coates, Chief of Staff Mylan and Hayden Rhudy, Senior Health Policy Advisor, The Office of Senator Orrin G. Hatch, on "Preparing for the Evolution of the Generic Drug and Biosimilar Industry", and chaired the Biosimilars Tracked Session in the afternoon. Other featured key conference speakers included FDA's Peter Beckerman, Senior Policy Advisor, Office of the Commissioner, and Russell Wesdyk, Center for Drug Evaluation and Research ("CDER"), Office of Pharmaceutical Science, and Bruce Pokras, Senior Corporate Counsel, Pfizer, and Elizabeth Jex, Attorney Advisor, Federal Trade Commission ("FTC").

Q1 Productions Regulatory Clearance & Commercialization of Generic Drugs & Biosimilars

In the kickoff panel, Coates questioned whether there was a "patent cliff", given the numerous opportunities to improve up on currently-marketed products and the inevitable development of a biosimilar pathway. Coates, moreover, had been involved in the Generic Drug User Fee Act ("GDUFA") negotiations and was hopeful that with the infusion of generic drug use fees starting in October 2012, the generic drug industry would see faster review times and a more responsive FDA when it came to new product development for generics.

In the same panel, Malkin asked Rhudy how the Biosimilars Price Competition and Innovation Act ("Biosimilars Act") came to be added to the Patient Protection and Affordable Care Act ("Affordable Care Act") in March 2010. Rhudy replied that once Congress had reached agreement on the exclusivity period for new biologicals (12 years), Congress essentially lifted the language from the most well-supported bill at the time without additional debate. Coates and Malkin then discussed why they thought that no applicant had filed a biosimilar application almost two and half years since the Biosimilars Act was passed. Much of their discussion regarding the lack of a developing biosimilars industry in the U.S. centered on the uncertain regulatory framework articulated by FDA and the complicated litigation pathway that would undoubtedly be costly for a biosimilar applicant to pursue. For instance, they noted that to date FDA had only partially discussed in its initial guidances the analytical process to compare a proposed biosimilar with its referenced product, while leaving out important details such as the clinical requirements for interchangeability, product naming, and what requirements FDA may waive. In response to these criticisms, Rhudy said that Congress would be focused more on the Affordable Care Act, now that the Supreme Court said that it was Constitutional, and the election, knowing that if they opened up the Biosimilars Act for debate, it might never be passed again. In essence, Rhudy said that Congress wanted to give more time to the Biosimilars Act to work, especially since Congress provided FDA with considerable discretion to help develop the industry and improve patients' access to affordable biological medicines.

Following the kickoff presentation, another key presentation featured Coates, Beckerman, and Wesdyk, speaking about GDUFA--why it was needed and what it hoped to accomplish. The speakers noted that since the industry took off with the Hatch-Waxman Act in 1984, the industry has continued to grow with increasing foreign product and active pharmaceutical ingredient development, which has strained FDA's limited resources. Wesdyk stressed that GDUFA differed from the previous iterations of the Prescription Drug User Fee Acts ("PDUFAs") in that it featured efficiency enhancements that promised to provide greater impact of the approximate $299 million in user fees per year at a relatively-low cost (less than one-half of one percent of generic drug sales), resulting in anticipated ten-month review cycles. Coates cautioned that since GDUFA mandated FDA to collect backlog fees for pending abbreviated new drug applications ("ANDAs") as of September 30, 2012, ANDA applicants should take a careful look at their ANDA portfolios to make sure that they withdraw any pending ANDAs that they were no longer pursuing. The FDA panelists noted that GDUFA had no waivers or grace period for backlog fees but thought most of the fees were "de minimis," noting that most GDUFA fees would be collected via a similar system as PDUFA. Failure to pay fees not tied to backlog fees, however, could lead to a product being deemed misbranded, the FDA panelists cautioned, but these fees had a limited grace period. The FDA panelists hoped that the fees would incentivize the generic drug industry to submit higher quality ANDAs resulting in fewer review cycles.

Continue reading "GDUFA and Biosimilars Key Topics at Q1 Productions Regulatory and Commercialization of Generic Drugs & Biosimilars in Alexandria" »

July 9, 2012

FLH Partner Andrew S. Wasson Speaks at FDLI's Inaugural Intellectual Property Throughout the Drug Development Lifecycle Conference on July 17 in Washington, D.C.

FDLILogo.jpgFDA Lawyers Blog is pleased to announce that Andrew S. Wason, Partner, in our New York office is a key presenter at the Food and Drug Law Institute's ("FDLI's") Intellectual Property Throughout the Drug Development Lifecycle: Opportunities and Challenges Conference in Washington, D.C. on July 17, 2012. FDLI's new Conference will address the intellectual property issues most important to patent litigators and in-house counsel in the pharmaceutical and generic industries, as well as the critical regulatory issues affecting these industries.

Course Topics:

  • The Role of IP During Drug Discovery and Pre-Clinical Drug Development
  • Brand Development Through IP in the Clinical Testing Phase
  • Post-Marketing IP Protection and Enforcement
  • Third Party IP: Preserving Freedom to Operate
This conference is designed for professionals in regulatory affairs, legal, and marketing, in the pharmaceutical and generic industries, as well as consulting, pharmacy and management representatives. This conference also targets intellectual property, and more specifically, patent attorneys.

FDA Lawyers Blog readers can join us at this program and receive a 15% discount off registration by using the promotional code: IPSP2012. Please feel free to share this code with your colleagues.

For more information and to register, visit the course website. We hope to see you there!

July 6, 2012

Nanotechnology: User Fee Bill Increases Funding for FDA Studies

nanotechnology.bmpThe Food and Drug Administration Safety and Innovation Act, otherwise known as the User Fee Bill, has passed through Congress and awaits the President's signature. This Bill, mostly known for implementing user fees for generic drug applications, also provides new programs to foster the study of nanomaterials in products regulated by FDA. Section 1126 of Title XI, Subsection C calls for the Secretary to "intensify and expand activities related to enhancing scientific knowledge regarding nanomaterials, ... to address issues relevant to the regulation of those products, including potential toxicology, the potential benefit of new therapies derived from nanotechnology, the effects of nanomaterials on biological systems, and the interaction of such nanomaterials with biological systems." This provision mirrors the Nanotechnology Regulatory Science Act of 2011 introduced by Sens. Ben Cardin (D-MD) and Mark Pryor (D-AR) last year, which stalled after its introduction in the Senate.

Nanomaterials utilize nanotechnology--manipulation of matter on the atomic and molecular scale. Nanomaterials, measured in billionths of a meter, range from 1- 100 nanometers (nm) and are used in a range of products, from paint and sunscreen to drugs and cosmetics. In 2010, the National Science Foundation estimated that nanotechnology-based products and manufacturing would add 2 million jobs and $1 trillion dollars in revenue to the world economy by 2015. These nanoproducts have different physical, chemical, and biological properties than conventionally-scaled materials, and some speculate that these properties may involve unknown risks to humans and our environment.

Written by Caroline Bercier

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The importance of nanomaterials has been recognized for some time. President Clinton advocated nanotechnology research, and President George W. Bush increased funding for nanotechnology development in 2003 with the passage of The 21st Century Nanotechnology Research and Development Act. However, this will be the first time that Congress has mandated that FDA study nanotechnology to evaluate the safety and toxicity of nanomaterials in consumer goods and products.

Continue reading "Nanotechnology: User Fee Bill Increases Funding for FDA Studies" »

July 5, 2012

European Pharmacovigilance Goes Into Effect July 2

eyemouthnew.jpgOn July 2, the much heralded new European Pharmacovigilance legislation came into operation. This new piece of legislation is aimed at promoting and protecting public health by strengthening the existing Europe-wide system for monitoring the safety and benefit-risk balance of medicines and provides regulators with a range of new or improved tools to ensure that patients are not exposed to unnecessary risks when taking medicines.

Highlights of the new legislation include:

  • The establishment of a new scientific committee, the Pharmacovigilance Risk Assessment Committee ("PRAC").

  • A clarification of the roles and responsibilities leading to more robust and rapid European Union ("EU") decision-making.

  • The engagement of patients and healthcare professionals in the regulatory process.

  • An improved collection of key information on medicines, e.g., through risk-proportionate, mandatory post-authorization safety and efficacy studies.

  • More transparency and better communication.

The first meeting of the new key committee, PRAC, will be on July 19 and 20, 2012. PRAC's mandate includes, among other things, "All aspects of the risk management of the use of medicinal products including the detection, assessment, minimization and communication relating to the risk of adverse reactions, having due regard to the therapeutic effect of the medicinal product, the design and evaluation of post-authorization safety studies and pharmacovigilance audit".

Continue reading "European Pharmacovigilance Goes Into Effect July 2" »