FDA Lawyers Blog

by Julie E. Kurzrok

It has long been known that there is an increased risk of cardiovascular complications including, for example, blood clots known as venous thromboembolisms ("VTEs") that result from the use of combined hormonal contraceptives ("CHCs"). Most CHCs are birth control pills containing the hormones estrogen and progestin. Recently, several new CHCs have been introduced into the market, and concerns have arisen regarding whether the cardiovascular risks are greater among these new preparations. The new CHCs are drospirenone/ethinyl estradiol tablets, the norelgestromin/ethinyl estradiol transdermal patch, and the etonogestrel/ethinyl estradiol vaginal ring. Drospirenone is a synthetic progestin, and the drospirenone tablets are marketed under the names Yaz®, Yasmin®, Beyaz®, and Safyral® (along with various generics). On October 27, 2011, the FDA published the final study report from its evaluation of these risks along with a safety statement regarding the possible increased risk of VTEs from drospirenone tablets.

FDA's study was a retrospective study entitled, "Combined Hormonal Contraceptives (CHCs) and the Risk of Cardiovascular Disease Endpoints" and it compared the risk of blood clots, among other things, in women who took three newly-marketed CHCs to women who took four older CHCs. The study examined the medical histories of 835,826 women from 2001 to 2007 and found that women taking the newly-marketed CHCs, including the drospirenone tablets, had a significantly higher risk of VTEs. Among only the users of the new formulations, the drospirenone tablets were the only ones with a significantly higher risk of VTEs. In conclusion, FDA stated that this study provided further evidence to link the drospirenone tablets with an increase in VTEs as compared to the other low-dose CHCs.

However, FDA has also seen conflicting results from six other studies of drospirenone pills and the risk of VTEs. Because of the conflicting results, FDA will hold a joint meeting with scientific advisors from the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on December 8, 2011. At the meeting FDA will review the results of its study and discuss the risks and benefits of drospirenone birth control pills, especially the risk of blood clots associated with these pills.

by Kyle Deighan

On October 14, Par Pharmaceutical, Inc. ("Par") filed a complaint against the United States of America and the Food and Drug Adminstration ("FDA") seeking a declaratory judgment that the first amendment bars the FDA from criminalizing pharmaceutical manufacturers for making statements regarding so called "off-label promotion" of approved drugs. Par argues that "the ongoing threat of prosecution for alleged off-label promotion based on Par's truthful and non-misleading speech to healthcare professionals concerning the FDA-approved use of Par's FDA-approved prescription drug currently chills Par's speech. Par seeks declaratory and injunctive relief to ensure its ability to engage in this protected speech free from the risk of criminal liability."

Par seeks this relief to allow it to discuss "off-label" uses for its drugs, which refers to use of the product outside that approved by the FDA. According to the complaint, off-label use is widespread and widely accepted by healthcare professionals, the U.S. government, and even the FDA. Par states that "FDA itself has recognized that 'in certain circumstances, off label uses of approved products are appropriate, rational, and accepted medical practice. FDA knows that there are important off label uses of approved drugs.'" Further, Par explains that the government encourages off-label use as well, as many off-label uses are subsidized by the federal government under the Medicare and Medicaid programs.

by Andrew S. Wasson

One would think that the passage of the Biologics Price Competition and Innovation Act in 2010 ("BPCIA") would have quieted the long debate on the appropriate period of exclusivity to award innovators of biological products. Not so. Even after the passage of the BPCIA, President Obama, for one, has been stubbornly attempting to chip away at the 12-year period of exclusivity guaranteed by the act. For example, the FY2012 Budget Plan called for reducing the period of exclusivity to seven years, citing a proposed $2.3 billion in savings by 2021. Supporters of a seven-year period threatened to revisit the issue in the Trans-Pacific Partnership trade talks which occurred this summer.

More recently, President Obama's "Plan for Economic Growth and Deficit Reduction" released in September 2011 yet again called for a reduction of the period of exclusivity to seven years. The plan also suggested prohibiting, "additional periods of exclusivity for brand biologics due minor changes in product formulations, a practice often referred to as 'evergreening.'" The plan asserts that a seven-year period of exclusivity retains "appropriate incentives" for biological innovators -- a point sharply disputed by said biological innovators. The report projected an increase in savings (up to $3.5 billion) over ten years.

In response, a group of fifty-one members of the House of Representatives, mostly Democrats, wrote President Obama, voicing their opposition to the proposed shorter length of exclusivity. The Representatives noted that twelve-year period is currently the law of the land, and enjoys bicameral, bipartisan support. The letter argues that the twelve-year period already strikes the balance between encouraging innovation and access to patients, especially considered upon the pre-BPCIA backdrop where innovators effectively enjoyed exclusivity in perpetuity. The Representatives warned that a shorter period of exclusivity could result in jobs moving overseas.

by Fitz Beckwith Collings

FDA has given the green light to AquaBounty's genetically-engineered salmon, the "AquAdvantage." The fast-growing fish, an Alaskan salmon supplemented with genes from the ocean pout and the Chinook salmon, can mature in 18 months instead of 36. The company first submitted its food to FDA for review in 1995 and now it appears, after a lengthy period of review and public comment, that it is closer than ever before to supermarket shelves. FDA's approval now sits on the desk of the White House's Office of Management and Budget.

As the world's first genetically-engineered animal food, AquAdvantage salmon would undoubtedly require strict oversight. AquaBounty insists that all its genetically-engineered salmon would be bred in inland farms, far from flood plains. But, in contrast to invasive species like the asian carp and the snakehead that must travel in a mating pair, a single escaped AquAdvantage salmon could breed with native salmon species and contaminate the gene pool. Of greater is concern is the possibility that, with its superior growth abilities and its improved resistance to cold temperatures, an escaped AquAdvantage salmon could eventually supplant Alaskan salmon in the wild.

In light of this threat, several groups have mobilized to oppose the approval, including the U.S. Senate. Senators Mark Begich (D-AK) and Lisa Murkowski (R-AK) have introduced an agricultural appropriations amendment--the Prevention of Escapement of Genetically Altered Salmon in the United States (PEGASUS) Act--that would make it a crime "to have custody, control, or possession of, with the intent to ship, transport, offer for sale, sell, or purchase genetically altered salmon or other marine fish, or a product containing genetically altered salmon or other marine fish, in interstate or foreign commerce." The senators sponsoring the amendment represent the state of Alaska, where salmon fisheries are relatively fertile. A similar bill was introduced in the House in June, and both bills would prevent FDA from using funds to approve genetically-engineered fish. House and Senate bills seeking mandatory labeling of genetically-engineered foods are also pending.

by Brian Malkin

On October 23, the 25th Annual Meeting and Exposition of the American Association of Pharmaceutical Scientists ("AAPS") kicked off with a Keynote Address from FDA' Director for the Center for Drug Evaluation and Research, Janet Woodcock, M.D., reflecting on the past 25 years of drug regulation and how they may help inform the next 25 years. Woodcock's premise was that the macroenvironment is a driver for the changes she has seen and expects to see in the future.

by Brian Malkin

FDA Lawyers Blog wanted to make you aware that there are important updates for their mobile apps for iPhones and Android smartphones. The apps feature FDA Lawyers Blog, key FDA news feeds, and a phone-ready HHS directory and can be downloaded directly from the Apple App Store and the Android Market free of charge. The iPhone update makes the app compatible with iOS5 and the Android app fixes a minor stability issue.

We previously mentioned that FDA Lawyers Blog was in the process of optimizing its blog to make it more readable on your iPhone or Android smartphone. We are almost done with those changes, but we will let you know when it is complete. We hope that you find the blog more readable on your smartphone whether you choose to use the apps or the native browser on your phone. Please note that if you choose not to select downloading one of the apps for your phone, the app pop-up will not appear again unles you clear the cache in your phone's browser.

Continue to watch for additional upgrades as we listen to your comments about what you need to be more productive with regard to FDA news and updates.

by Brian Malkin

On October 19, FDA published in the Federal Register proposed amendments to its 1992 Orphan Drug Regulations. According to the notice, the amendments "are intended to clarify regulatory provisions and make minor improvements to address issues that have arisen since those regulations were issued." FDA said it has reviewed over 3,350 orphan-drug designation requests since the 1992 regulation became final. This proposed rule follows FDA's announcement of boosting its orphan drug program, as we reported here. Comments are due by January 17, 2012 on the proposed rule.

The specific issues addressed in the proposed rule include:

(1) Demonstration of an appropriate "orphan subset" of persons with a particular disease or condition that otherwise affects 200,000 or more people in the United States, for the purpose of designating a drug for use in that subset;

(2) Eligibility for orphan-drug designation of a drug that is otherwise the same orphan-drug indication as a previously-approved drug;

(3) Eligibility for multiple orphan-drug exclusive approvals when a designated orphan drug is separately approved for use in different subset of the rare disease or condition;

(4) Requirement for demonstrating clinical superiority for the purpose of orphan-drug exclusive approval;

(5) Requirement for submitting the name of the drug in an orphan-drug designation request;

(6) Required drug description and scientific rationale in a designation request;

(7) Required information in a designation request relating to the sponsor's interest in the drug;

(8) Timing of a request for orphan-drug designation;

(9) Responding to a deficiency letter from FDA on an orphan-drug designation request;

(10) FDA publication of information regarding designated orphan drugs;

(11) FDA recognition of orphan-drug exclusive approval;

(12) Miscellaneous terminology changes; and

(13) An address change.

by Charles J. Raubicheck

The Generic Drug User Fee Agreement ("GDUFA") negotiated between the Agency and industry trade associations calls for abbreviated new drug application ("ANDA") applicants to pay a voluntary one-time fee to reduce the significant backlog of ANDAs under review. The payments would be used to hire more reviewers and speed up approvals.

FDA is weighing the impact of the fee on companies who elect to pay it to release particular products from the backlog for stepped-up approval, versus companies who do not. On October 5, Office of Generic Drugs ("OGD") Acting Director Keith Webber told Generic Pharmaceuticals Association ("GPhA") Technical Conference attendees that a major issue could arise--whether a backlogged drug for which a fee is not paid can be denied approval.

Fairness will play a part, Webber said. Payers may contest drug approvals for non-payers. On the other hand, Webber noted that a public health need for a low-cost generic product, where the applicant is a non-payer, would need to be addressed. (Also, smaller generic companies may lack the resources to pay the fee.)

The FDA-industry agreement still has to be approved by Congress in user fee legislation.

by Kyle Deighan

Counterfeit drugs are widely recognized as a serious and growing public health hazard. Around the world, they have become a multi-billion dollar industry, with some estimating sales as high as $75 billion in 2010 alone. Whether to eliminate the risk to the public or to regain profits lost to counterfeiters, the pharmaceutical drug industry has taken notice of the problem, exploring various methods to thwart production and distribution of the phony drug products.

Last week, FDA stepped in when they released a final Guidance directing manufacturers in the pharmaceutical industry on the implementation of a specific anticounterfeiting method--the use of physical-chemical identifiers in drugs. The guide, titled "Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting," defines physical-chemical identifiers ("PCIDs") as a "substance or combination of substances possessing a unique physical or chemical property that unequivocally identifies and authenticates a drug product or dosage form."

Essentially, PCIDs are intended to make drug products more difficult to duplicate. Manufacturers add a small amount of an ingredient, the PCID, to the drug product, and "a unique physical-chemical characteristic of that ingredient makes it possible to detect and authenticate legitimate dosage forms, and to identify counterfeits." The guide states that PCIDs include inks, pigments, flavors, and molecular taggants, which may be detected by a patient simply observing the drug, or by more complex means using detection instruments.

by Brian Malkin

On December I, FDA plans to hold a Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee to discuss "REMS-related topics" including the Risk Evaluation and Mitigation Strategies ("REMS") program for isotretinoin called iPLEDGE.

iPLEDGE is the latest version of one of the oldest and most restrictive risk management programs that continues to receive criticisms because of its mandatory requirements that are viewed by some as burdensome while others as not restrictive enough. Specifically, iPLEDGE fails to do what it set out to do--prevent isotretinoin-related pregnancies that have a high likelihood to result in birth defects even for small amounts given during the early weeks after conception, when a woman may not know that she is pregnant. Birth defects associated with isotretinoin exposure to fetuses have included: hydrocephaly (enlargement of the fluid-filled spaces in the brain), microcephaly (small head and brain), mental retardation and other learning disabilities, ear and eye abnormalities, cleft palate and other facial abnormalities, and heart defects. If that is not enough, the drug also increases the risk of premature birth and infant death.

FDA Lawyers Blog is proud to announce that for six years years running, FLH Partner Charles J. Raubicheck as been recognized as an FDA "Super Lawyer" in Thompson Reuter's Super Lawyers publication for the New York Metro area. The process to become a "Super Lawyer" begins with peer nominations, then candidate research, and ends with a review of candidates by their peers within their primary area of practice.

by Charles J. Raubicheck

On September 27, FDA and Del Monte Fresh Produce N.A. resolved their ongoing battle over imports of cantaloupes from Guatemala in what has been called an "amicable resolution."

In March of this year, the Agency linked these melons to a salmonella outbreak in Oregon, and imposed an import alert on July 15 detaining the produce from being brought into the U.S. Del Monte, the country's largest importer of cantaloupes, then sued FDA, asserting that the alert was unjustified because it was based on the Agency's speculative and erroneous claim that the cantaloupes were harvested and cleaned under contaminated conditions. Del Monte also files an ethics complaint against Oregon's senor epidemiologist William Keene and threatened to sue Oregon's health authorities for making the implication against Del Monte without evidence that its cantelopes had tested positive for the outbreak strain, Salmonella Panama.

Former FDA Associate Commissioner of Foods David Acheson and Oregon health officials reportedly are concerned that Del Monte's suit and threatened suit could hamper future alerts to consumers of potential food-related health risks, noting that the suit questions the role of epidemiology as a valid scientific methodology to trace foodborne illness.

A statment by FDA said that FDA has now lifted the alert after tests for bacteria proved negative, and a third-party audit showed that Del Monte's plant is following GMPs. In turn, the company has dropped its lawsuit.

by Howard E. Rosenberg, Ph.D.

The European Commission has updated its proposals with regard to the product information available to patients. Unlike in the United States, pharmaceutical companies in Europe cannot advertise their wares direct to the public, nor can they make claims about a medicine without clearance from Health Authorities and even then only in acceptable formats. The Commission's initial 2008 proposals have been updated to incorporate the European Parliament's amendments, the emphasis being on the rights and interests of patients.

The European Commission's press release explains "that patients are increasingly interested in learning more about the medicines they take and want more of a say in how they are treated. At the same time, patients are confronted with a growing volume of information from various sources and often find it difficult to identify reliable information about medicines. The increased use of the internet over recent years makes the need for clarity even more important. Online information on medicines must be accurate and reliable."

Some key elements of the amended proposals are:

1. Only certain information on prescription-only medicines will be allowed, e.g., information on label and package leaflets, prices, pre-clinical tests and clinical trials of the medicine concerned and on the instructions for correct use.
2. Only certain channels of communication will be allowed for providing information, e.g. via officially registered internet websites or through printed information provided this has been specifically requested by members of the public.

by Scot Pittman

FDA has put forth significant efforts in trying to tweak its 510(k) device approval pathway, which has created discontent among medical device companies for many years. In its most recent attempt to improve the medical device approval process, FDA released draft guidelines "De Novo Classification Process (Evaluation of Automatic Class III Designation)" last Monday.

De Novo Guidance

A typical low- to moderate-risk medical device approval requires either FDA clearance of a premarket notification or approval of a 510(k) submission. 510(k) submissions require a demonstration that the new device is substantially equivalent to an already legally-marketed device. The De Novo Classification Process attempts to streamline device approval for low- to moderate-risk devices that have been classified as Class III because they cannot be shown to be substantially equivalent to any legally market devices. In addition, the guidance also describes a mechanism for obtaining timely input on the type of data necessary to support de novo classification of a suitable device. When this guidance is final, it will replace "New Section 513(f)(2) - Evaluation of Automatic Class III Designation, Guidance for Industry and CDRH Staff" (February 19, 1998).

by Fitz Beckwith Collings

Center for Food Safety, have asked FDA to bring its regulatory power to bear on genetically-engineered ("GE") foods to prevent economic fraud and consumer confusion. They seek several definitional changes in the Federal Food, Drug, and Cosmetic Act ("FD&C Act") and U.S. Code of Federal Regulations ("C.F.R."), as well as the institution of mandatory labeling for all GE foods.

Definitional Changes

First up is rescission of FDA's 1992 policy statement regarding the definition of a "material" production process under FD&C Act Section 201(n). The current definition turns on processes that a consumer can detect using his senses. Petitioners seek to define a production process as material "if it results in a change to a food at the molecular or genetic level because a significant share of consumers would find it relevant to their purchasing decisions." Changing the definition, they argue, is consistent with FDA's authority and a failure to change it would be arbitrary, capricious, or contrary to the law.

Next, petitioners request the inclusion of definitions for "genetic engineering" and "genetically engineered food." The definitions highlight petitioners' food safety argument. "Genetic engineering" means "a process that alters an organism at the molecular or cellular level by means that are not possible under natural conditions or processes," and specifically excludes established selection processes like breeding, conjugation, fermentation, hybridization, in vitro fertilization, and tissue culture.

by Erin A. Lawrence

On September 29, FDA added a supplement to the 2009 Food Code that addresses recommendations made at the 2010 Meeting of the Conference for Food Protection. The new supplement would require businesses in the food service industry to hire certified food protection managers. The supplement aims to mitigate risk factors that contribute to foodborne illnesses.

FDA's Food Code is a set of model food-safety regulations for keeping food safe at retail and food-service operations including restaurants, schools, and food stores. FDA guidelines are not mandatory, but are adopted by many states to delineate food safety standards. Food Codes are issued by FDA every four years. The next complete revision to the Food Code will be published in 2013.

Forty-nine states pattern their food safety codes after versions of the federal Model Food Code. Twenty-four states already require certified food protection managers. To become a certified food protection manager, an employee must complete an educational program that is approved by a Conference for Food Protection-recognized agency. Recognized agencies include the National Restaurant Association's ServSafe program, Prometric, and the National Registry of Food Safety Professionals. The supplement calls for "[a]t least one employee that has supervisory and management responsibility and the authority to direct and control food preparation and service shall be a certified food protection manager who has shown proficiency of required information through passing a test that is part of an accredited program. " The certified food protection manager would be responsible for: 1) developing and implementing the operating procedures required by the food code; 2) apprise employees about their obligation to report certain health conditions; 3) make sure that any food delivered after operating hours is done so in a way that does not create a food safety hazard; 4) mandate a proper clean-up plan for an employee or customer that has gotten physically ill; 5) educate employees regarding the guidelines of using bare hands with ready-to-eat foods and; 6) clarifying the guidelines for storage of meat and poultry.

In addition to the supplement, FDA also announced that it established a cooperative agreement with the National Association of County and City Health Officials ("NACCHO"). Under the agreement, FDA and NACCHO will promote the use of best practices by local authorities, develop tools to strengthen retail food safety oversight, and implement FDA's Voluntary National Retail Food Regulatory Program Standards for retail food regulatory programs.

by Brian Malkin

FDA Lawyers Blog is pleased to announce the arrival of its new mobile apps for iPhones and Android smartphones. FDA Lawyers Blog, key FDA news feeds, and a phone-ready HHS directory are now available in the applications developed for iPhones and Android phones. Both apps can be downloaded directly from the Apple App Store and the Android Market free of charge. In addition, FDA Lawyers Blog is in the process of optimizing its blog to make it more readable on your iPhone or Android smartphone. Some of those changes have been implemented already, and we will announce them once the final mobile style sheets are in place.

Since we went live last year, FDA Lawyers Blog has provided cutting-edge, social media optimization for its blog featuring FDA news and updates for FDA lawyers and other interested users. Our blog features links and feeds to Facebook, Twitter, and LinkedIn with various options to share our blogs, including Twitter "tweets" and Facebook "likes" for individual posts. FDA Lawyers Blog's mobile applications feature similar sharing options but now adds FDA news feeds and a phone-ready HHS directory to make calling FDA even easier on your Apple or Android smartphone. With these enhancements, FDA Lawyers Blog takes its blog to a new global level of accessibility and usefulness for professionals in the field of FDA law. Continue to watch for additional upgrades as we listen to your comments about what you need to be more productive with regard to FDA news and updates.

Along these lines, please let us know what you think about the iPhone and Android apps. We are in the process of creating additional functionality for both the applications and mobile versions of FDA Lawyers Blog and look forward to providing our readers with additional mobile features to access the FDA news and updates you need for now and in the future.

by Brian Malkin

On October 5, FDA's David T. Read, Regulatory Counsel, Office of Generic Drugs ("OGD"), Center for Drug Evaluation and Research, presented a snapshot of generic drug applications and approvals since the Hatch-Waxman Amendments and the challenges going forward.

Acknowledging that OGD has a backlog of over two thousand abbreviated new drug applications ("ANDA") with a median 27.88 month review cycle, Read cited to a number of factors contributing the problem. First, OGD needs more resources (i.e., reviewers) to get rid of the backlog, which may be helped by the promised Generic Drug User Fee Act ("GDUFA") once it becomes law. Read explained that 505(q) citizen petitions (petitions that FDA must respond to within 180 days because they interfere with generic drug approvals among other things) and products with increased complexity also contributed to the problem. Read cited FDA's response to the enoxaparin citizen petition as an example of the enormous drain on resources caused by complex issues (in that instance, tough questions of "sameness").

In addition to GDUFA, Read explained that other potential solutions could include the better prioritization of ANDAs, and increased communication of the need for higher quality ANDAs and generic products. Here, Read mentioned ongoing complaints about antiepileptic drugs where practitioners and others continued to complain breakthrough seizures occurring in brand-to-generic switches, generic-to-generic switches, and generic-to-brand switches. The problem, Read noted, was that the "data stinks": meaning that the complaint of breakthrough seizures is based on anecdotal data rather than well-controlled studies.

by Kyle Deighan

The year 2010 saw a record 178 reported drug shortages in the United States. According to various sources, that number has already reached nearly 200 this year. The shortages include cancer drugs, anesthesia drugs, and other critical medications, the U.S. Food and Drug Administration ("FDA") reports. These shortages lead to dire consequences for patients that rely on the drugs, prompting many, including FDA, to take notice.

More recently, FDA held a day-long hearing on September 26th that was attended by medical and consumer groups, researchers and industry representatives, seeking to identify the causes and effects of shortages and strategies to address the problem. In addition to various presentations on the current status of drug shortages, attendees discussed the impact of shortages from the public's perspective and the health care provider's prospective. One recommended solution required manufacturers to notify FDA of drugs expected to be in short supply within a six month period. Currently, FDA requires those companies that are the sole source of medically necessary drugs to notify FDA at least 6 months in advance if the product will be discontinued. However, those companies face no penalties if they do not do so. According to FDA, early notice will allow it to more effectively address and work to avoid a shortage. FDA was reportedly able to prevent 38 shortages in 2010 when manufacturers voluntarily reported potential supply disruptions.

Frommer Lawrence & Haug LLP Partner Brian J. Malkin will speak on a hot issue concerning 180-day exclusivity for first Paragraph IV applicant generics, "Exclusivities and Forfeitures: New Developments, Controversies and Concerns" at the American Conference Institute's 12th Annual Maximizing Pharmaceutical Patent Life Cycles Conference New York City, held from October 4-5, 2011. Now that FDA has issued a number of forfeiture rulings, some of which have been successfully challenged in court, FDA has started issuing decisions without offering an opportunity for public comments. Come and find out the latest developments in this area and how it may affect your pharmaceutical product development.

FDA Lawyers Blog readers may obtain a $200 discount by mentioning FDA Lawyers Blog and using the code "FDA 200". You may register for the conference here.

by Andrew S. Wasson

Today FDA announced a plan to create a network of outside scientific experts who would assist the Center for Devices and Radiological Health ("CDRH"). While CDRH currently employs a scientific staff and solicits the advice of outside experts, FDA hopes that the proposed network will provide FDA with "rapid access to specific specialized knowledge about emerging technology." FDA announced a pilot program which will run from September 30, 2011 to December 30, 2011. FDA released draft standard operating procedures ("SOPs") which will be open for comment starting on October 6, 2011: Expert Utilization Standard Operating Procedure and Expert Enrollment Standard Operating Procedure.

The draft SOPs clearly state that the network of experts is not intended to supplant the current systems used by FDA. FDA explains that the Agency derives expertise from a number of external sources: (1) advisory committee meetings, (2) scientific literature and conferences, (3) public workshops attended by scientific experts, and (4) ad hoc interactions with other federal scientists outside of FDA. The documents state that questions to external experts as a part of this program "should be limited to those that are scientific and necessary for CDRH staff to effectively complete their work and are not suitable for using any of the existing mechanisms outlined above." The SOPs also clarify that the network of experts will not make give policy advice or make policy decisions. Rather, "network members will share their particular expertise on specific topics to help center staff form their own conclusions." FDA's goal is to allow FDA scientists to draw on expertise outside of the current pool in a time-sensitive fashion.

by Fitz Beckwith Collings

Eli Lilly recently expanded its two-year-old open innovation program--the Phenotypic Drug Discovery Initiative--to include three distinct components for testing promising new drugs. The first component, PD(2), screens molecules submitted by independent researchers in the hope of identifying compounds for treatment that have novel mechanisms of action or operative in novel pathways. Lilly identifies several strategic areas of interest, including endocrine and cardiovascular systems, oncology, and neuroscience. The second component, TD(2), screens molecules that may interact with known disease targets. The third component screens molecules that may act against multi-drug resistant tuberculosis.

Lilly's open innovation initiative aims to crowd-source pharmaceutical development, in the hope that finding the medicines of the future could be as easy as finding a few red balloons. To participate, scientists upload conforming molecules to openinnovation.Lilly.com, and Lilly provides a comprehensive testing report. Scientists can then use advanced computational tools on Lilly's website to interact with the data.

In exchange for testing the molecules, Lilly gains the right of first negotiation for a collaborative or licensing agreement with the scientist. The scientist retains all other intellectual property rights, and the ability to publish and disseminate the data freely if no agreement is reached. Furthermore, if the scientist has identified a compound for tuberculosis, the scientist may elect to proceed down a non-profit pathway of drug development. Similar programs have been created by GlaxoSmithKline (for medicines to treat third-world diseases like malaria) and Sanofi (for hearing-loss treatments).