FDA Lawyers Blog

On September 19, ten top U.S. and European drugmakers announced that they have formed a new nonprofit organization called TransCelerate BioPharma Inc. ("TransCelerate") to help improve how experimental drugs are tested to get them to patients sooner. The New York Times broke the story, along with the Associated Press and Reuters getting the word out for this organization that has been in the works for about a year.

The ten companies are: (1) Abbott Laboratories Inc., (2) AstraZeneca Plc, (3) Boehringer Ingelheim, (4) Bristol-Myers Squibb Co., (5) Eli Lilly and Co., (6) GlaxoSmithKline Plc, (7) Johnson & Johnson, (8) Pfizer Inc., (9) Roche Holding's AG Genentech, and (10) Sanofi SA. TransCelerate's headquarters will be in Philadelphia, Pennsylvania, which it hopes to open later this year. All of the companies will contribute financial and other resources but for right now scientists and other staff are working from their corporate offices.

FDA's Director for the Center for Drug Evaluation and Research ("CDER"), Janet Woodcock, M.D., supported the move, said in a statement,

We applaud the companies in TransCelerate BioPharma for joining forces to address a series of longstanding challenges in new drug development.... This collaborative approach in the pre-competitive arena ... has the promise to lead to new paradigms and cost savings in drug development, all of which would strengthen the industry and its ability to develop innovative and much-needed therapies for patients.

The interim chief of the effort is Garry Neil, former Corporate Vice President for Science and Technology at Johnson& Johnson. "There's never been anything like this to take on these big challenges," Neil said, who has so far offered no details on how big this project will get other than the initial focus would be five projects to make clinical trials more efficient with a budget in the millions of dollars. "We want to simplify, standardize, and also raise quality. ... We worry about potentially promising drugs which might not get studies unless we can increase the overall efficiency of the system. I think it will make it easier for companies," Neil added.

On September 18, FDA approved the first medical device approved for ultrasound imaging for use in standard mammography screenings for women with dense breast tissue. Sunnyvale, California-based U-Systems manufactures the device called the somo-v® Platinum Automated Breast Ultrasound System ("ABUS"). The decision follows a unanimous recommendation to approve the device by an advisory panel.

Dense breasts have a high amount of connective and glandular tissue compared to breasts that have a higher percentage of fatty tissue. Physicians can determine whether a woman has dense breast tissue via a mammography exam. The National Cancer Institute currently estimates that about 40 percent of the women having mammography screening have dense breasts. These women appear to have a higher risk for breast cancer as well.

Mammography is a low-dose x-ray image of the breast. Until the ABUS, mammograms of breasts with dense tissue show both fibroglandular breast tissue and tumors as solid white areas on a mammogram, making results difficult to interpret. Often the dense breast tissue would obscure smaller breast tumors, which could delay breast cancer detection.

A research letter published online in the Journal of the American Medical Association ("JAMA") last Tuesday reports findings that pharmaceutical advertisements have a tendency to minimize potential adverse effects when the products they promote become available over-the-counter ("OTC"). The researchers attribute this shift in content to the differences in prescription drug advertising standards, governed by FDA, and those for OTC advertising, governed by the Federal Trade Commission ("FTC"). FDA requires that ads present a "fair balance" of the risks and benefits of a drug, a requirement that is absent from FTC's "reasonable consumer" standard. Commentators note that the FDA regulations are better equipped to ensure against "active deception."

The research endeavor, sponsored by CVS Caremark, considered four drugs that transitioned from prescription to OTC status within the last ten years: Claritin® (loratidine), Prilosec® (omeprazole), Xenical®/Alli® (orlistat), and Zyrtec® (cetirizine). It examined 133 total television and print advertising materials from twenty-four months prior to, through six months after, each transition, and found that the percentage of advertisements that referenced side effects plummeted from 70% while prescription only to 11% once available OTC. Conversely, the proportion describing drug benefits jumped from 83% to 97%. The study further reports that OTC advertisements frequently omit the generic names of drugs, "a powerful tool for the patient as a consumer in that it helps tie together scientific information on the drug from different places." Roughly 50% of the OTC ads mentioned the generic name, while over 95% had when the drugs were available by prescription only.

"In many, many cases information about risks simply disappeared from the ads once the drugs became [OTC]," remarked head researcher Dr. Jeremy Greene. This likely contributes to erroneous consumer beliefs that relocation out from behind the pharmacy counter automatically indicates a safer product. With 106 ingredients, indications, or dosage strengths having made the Rx-to-OTC switch since 1976, it is unlikely that this is always the case. Greene highlighted the danger of this situation given the frequency of overdoses on some of the most commonly used OTC drugs, such as acetaminophen (Tylenol®) and ibuprofen (Advil®). A 2006 study, for example, estimated over 450 acetaminophen overdose-related fatalities each year.

This research raises the question of where consumers can turn to obtain important information on potential side effects, if they are not receiving it from product ads or prescribers/suppliers. While some information is available online (such as at otcsafety.org or webmd.com), tracking it down requires active effort. Consumer Healthcare Products Association (CHPA) policy does note that the OTC label "is the most important element of a nonprescription drug," and "clearly lists a product's active ingredient, purpose, uses, warnings, directions, other information, and inactive ingredients." In an age dominated by electronic media, however, consumers are inevitably paying more attention to television and online/print advertising than drug labels. Also of note is that current OTC labeling requirements were promulgated by FDA, not FTC.

The Caremark study findings indicate that reform may be necessary to ensure transparency of consumer risks in the OTC pharmaceutical market, whether it be FDA oversight of OTC drugs or FTC adoption of stricter advertising criterion. With 240 million Americans currently using OTC medicines, according to a January 2012 CHPA report, it is a matter that deserves serious consideration.

FDA's various user fee acts ("UFAs") have not reached their implementation date in October 2012, yet FDA has already begun announcing staff changes to help with overseeing the new changes.

On the Commissioner level, Peter Lurie will be replacing David Dorsey as Acting Associate Commissioner for Policy and Planning. In a September 12 staff memorandum, FDA Commissioner Margaret A. Hamburg, M.D. announced the departure. Dorsey is leaving FDA to be a senior director in global regulatory policy and intelligence at Janssen Research & Development LLC in Rockville, Maryland. Hamburg wrote in the staff memorandum:

Throughout his long government tenure, David's colleagues repeatedly have sought him out for his extraordinary depth of knowledge, his vast experience on the Hill and at the agency, his thoughtfulness, and his patience under pressure. . . . David's departure will be a loss to the agency, and we will miss him.

(The Pink Sheet, September 13, 2012).

This changes follows a few earlier FDA staff changes at the Commissioner level and elsewhere last month. First, Associate Commissioner for Regulatory Affairs Dona Carrigan was announced as the new Director of FDA's Europe Office and Senior Advisor for Global Operations, stationed in Brussels, Belgium. Carrigan's new position is designed to help implement the Agency's strategic and risk-based global industry oversight and enforcement. Next, Melinda Plaisier will be Acting Associate Commissioner for Regulatory Affairs effective October 1. Plaisier was previously the Regional Food and Drug Director in the Office of Regulatory Affairs' central region, and before that she was Associate Commissioner for Legislation and Associate Commissioner for International Programs.

On September 12, FDA's Center for Drug Evaluation and Research ("CDER") Director Janet Woodcock, M.D. reported FDA's biosimilars program will be "under-resourced" until the biosimilars industry develops at a Drug Information Association ("DIA")/FDA Biosimilars Conference: Guidances, Science, and BsUFA. "This is going to be an under-resourced program for the next few years because that's how it is ... That'll cause, I think, some struggle, especially with allocation of resources amongst all the important activities that we do at FDA," Woodcock said. (The Pink Sheet, September 12, 2012.)

Once again, FDA reported that while FDA has the authority to approve biosimilars, FDA still has yet to receive a single biosimilars application, called 351(k) applications, based on their new statutory provision. FDA reported the same numbers that were discussed in two recent conferences discussing biosimilars that we reported on here and here: 11 investigational new drug applications ("INDs") and 30 pre-IND meetings with the Agency concerning biosimilars. FDA recently did approve Teva's biosimilar version of Amgen, Inc.'s Neupogen® (filgrastim), but Teva submitted this as a full biologics license application ("BLA") rather than a biosimilar, because reportedly Teva believed the biosimilar pathway was either infeasible or not ready for commercial approvals yet.

Woodcock speculated that annual product fee payments for sponsors with INDs will likely be the initial source of extra funding that FDA receives, with 351(k) fees to follow only after sponsors start submitting these applications. Under the Biosimilars User Fee Act ("BsUFA") that will become effective on October 1, 2012 along with other user fees, barring any possible derailment, which we reported here, the development fees are only 10% of the marketing application fees for each year, but the payments will be subtracted from the marketing application fee, once filed. For example, in Fiscal Year 2013, the product development fee for a 351(k) application is $195,880 with 351(k) application fees set at about $1.96 million per application.

On January 2, 2013, barely three months after FDA's new user fee programs go into effect, certain mandated spending reductions, called sequestration, also may go into effect that could prevent FDA from using the user fees it collects from industry. A Congressional Super Committee failed to find the required $1.2 trillion in cuts over ten years by a November 2011 deadline. The combined effect of lost taxpayer and user fees projected by Maryland-based Alliance for a Stronger FDA, would be an initial $294 million out of a $3.65 billion budget.

The catch comes from a component of FDA's user fee programs known as the "trigger" that requires a certain baseline of taxpayer funds to go to FDA, so industry user fees supplement rather than fund FDA's operations. FDA's projected funding for fiscal year 2013, set at $2.5 billion, would be cut by an across-the-board, 8% cut in federal government, coined as a "fiscal cliff", imposed to help curb the ever-increasing government debt. While FDA's cut of about $200 million would not normally hit the trigger to prevent FDA's use of user fees, Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA, told Anna Edney from Bloomberg that the Obama Administration may still sequester FDA's user fee funds to help with federal spending reduction goals. The exact trigger levels, moreover, are based on formulas that include consumer inflation and past spending, which so far FDA has declined to comment on.

According to Grossman, if this occurs, about $68 million in drug and device user fees and $40 million in tobacco-company payments would be diverted to a U.S. Treasury Department account that would "reduce government because it would reduce what they can do." Faced with the sudden loss of these funds, drug industry experts have speculated that FDA would be forced to lay off personnel and take other measures to reduce costs.

On September 6, District of Columbia District Judge Amy Berman Jackson granted FDA's motion to dismiss claims brought by K-V Pharmaceutical Company ("K-V") either because the claims were unreviewable as discretionary FDA enforcement activities or failed to state a claim. Jackson's Memorandum Opinion helps solidify FDA's position that its discretion not to take an enforcement action is presumed to be immune from review unless Congress has otherwise provided "meaningful standards . .. for defining the limits of that discretion." (citing Heckler v. Chaney),

Makena™ is essentially a story about K-V's bid to take advantage of provisions under the Orphan Drug Act to obtain seven years of exclusivity to market the active ingredient in Makena™ (17-hydroxyprogesterone caproate) for women who have had a singleton pregnancy and a history of prior preterm delivery. Under the Orphan Drug Act, no other company can obtain approval to market the same active ingredient for this indication, which affects less than 200,000 patients per year in the United States, until this exclusivity would have expired. Prior to approval of Makena™, however, pharmacies had been compounding the same active ingredient for individual patients based on individual prescriptions--not a marketed product--at far less cost, around $10-20 per injection rather than the initial price of Makena™ at $1500 per injection, or up to $30,000 for the entire treatment. For more background, see, for example, an earlier blog here.

K-V had hoped that orphan drug approval would block competitors for seven years and its approval would make FDA take additional enforcement actions against pharmacies that had been routinely compounding the same active ingredient for the same indication. Indeed, many had feared, including a number of Congressmen, that FDA would take such actions, causing the cost of treatment to dramatically rise, under a general assumption that an approved drug product would be preferred, from a public health perspective, over a compounded product.

FLH Partner Charles J. Raubicheck, head of our firm's FDA/Regulatory practice, will moderate a panel and deliver an address at the upcoming Food and Drug Law Institute's Conference "U.S. & Brazil: Navigating New Frontiers in Pharmaceutical, Medical Device and Food Law and Regulation." The conference will be held on September 10-11, 2012 in São Paolo, Brazil.

Brazil has the world's 6th largest economy, and is becoming a leader in research and development in the drug, medical device and food industries. The Conference is a forum for representatives of companies, venture capital firms, government agencies, law firms and other interested groups to focus on business opportunities and regulatory hurdles in both Brazil and the U.S. Speakers will include officials of FDA and the Brazilian National Health Surveillance Agency ("ANVISA").

Mr. Raubicheck is moderating the "Medical Products: IP Issues" panel, which will discuss the interaction between regulatory and intellectual property issues applicable to pharmaceuticals and medical devices. Other panel members include Nuno Pires de Carvalho, Director, Intellectual Property and Competition Policy Division, World Intellectual Property Organization ("WIPO"), and Albert Keyack, Latin America Attaché, United States Patent and Trademark Office.

Mr. Raubicheck's presentation is entitled "NDAs, ANDAs, FDA's Orange Book, and Patent Term Extensions." Frommer Lawrence & Haug is a sponsor of the event.

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

According to the EMA, the Inventory aims to enable:

• Companies to identify opportunities for business development;

• The PDCO to judge the need for medicines and studies when assessing draft pediatric investigation plans, waivers and deferrals; and

• Healthcare professionals and patients to have an information source available to support their decisions as to which medicines.

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

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

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

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

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

Nominations are due no later than September 7, 2012.

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

• We're primarily interested in blawgs in which the author is recognizable as someone working in a legal field or studying law in the vast majority of his or her posts.
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• We are not interested in blawgs that more or less exist to promote the author's products and services.

The ABA discourages nominations from:

• Blawggers who nominate their own blawgs or blawgs to which they have previously contributed posts.
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Thank you for reading FDA Lawyers Blog. We have been running for more than two years strong and plan to keep it that way. We also invite you to send us a comment through the blog if there are topics or things that you think we could do better. For example, in addition to our unique resources on Biosimilars and European Drug Law, what additional resources would be useful for you?

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

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

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

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

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

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

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

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

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

The Third Circuit originally held:

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

For more background on this case, please see one of our blogs here.

Malkin was cited in the article in the following manner:

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

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

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

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

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

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

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