I wrote a subsequent article saying whats taking you so long, josh. So ive been waiting for him to return the favor, and i just got a copy of it. So i appreciate it very much. Thanks for the opportunity to be here today. Thanks john hopkins for hoestin this, and pew for providing space. Transparency can be a powerful tool for innovation. New platforms for visualizing large complex data sets present important new opportunities for the research and Development Community for regulators and for clinicians. It allows people to harness data to advance the safe and effective and Efficient Development for medical needs and to communicate information supporting regulatory Decision Making in ways that engender Greater Public confidence in those decisions. The fdas goal is to advance transparency without reducing incentives to innovate. This can be accomplished by meeting our statutory responsibility for protecting confidential, commercial information, trade secrets and private data while disseminating more information gnat supports and informs more regulatory decisions and patient care when ones products are approved for use. With these safe guards in place, transparency is a tide that can lend to all boats. To identify areas requiring additional postmarket research and to generate the data necessary to meet fdas Gold Standard for assuring product safety and efficacy. And fdas modern transparency strategy began with the doctors leadership at the Transparency Task force and subsequent recommendations in 2010. And we continue to expand fdas commitment to transparency today. But stakeholders continue to request Greater Transparency in the drug approval process and greater access to usable information on those approvals. And i believe theyre right. We need to look for ways to be more forthcoming with the information we have within the boundaries off our statute and your obligations. Much of our information concerns products that are integral to peoples family, the food they eat, the pets they love, and the medicines they use. People deserve to have as much information about these products as we can possibly eliabreliabl provide. We have a Public Health obligation to keep people fully informed of the safety and benefits of the products they use to improve their lives, and were taking some new steps to fulfill these commitments. Today im announcing two initiatives i hope will provide Greater Transparency and efficiency in review. Together these initiatives will give patients and researchers new insight into the data and Decision Making behind the approval process. First beginning this month our center for drugs is launching a pilot to evaluate whether disclosing certain summaries of clinical information called Clinical Study reports or csrs following the approval of new drug applications can improve the publics access to drug information. To start the pilot can include up to nine drug applications to sponsor and volunteers to participate. The pilot is going to test the process for selecting, redacting, and posting csr information on a public website drugs fda that fda uses to provide approval information on new drugs. Applications to be included in the pilot will be selected based on criteria including their novelty, scientific interest and whether or not the drug is new molecul molecular entity. A csr is portion of a drug file related to a Clinical Trial that contains a detailed summary on the methods and results of the trial. Csr is a scientific document addressing the efficacy and safety. We suggest making it available after approval will provide stakeholders on more information on Clinical Evidence fdas Decision Making process. It can help those interested in that detailed data. For example, academic researchers who want to study a specific drug and need access to summaries of bottom line information in order to inform that research. This will be the first time that fda is proactively disclosing the reports to the public. It will include study report bodies, the study protocol and amendments and statistical analsy plans for each pivotal study. Clinical summary reports will be posted on a new fda web page describing the program in addition to new drugs appearing on the fda. With the drug information alongside the time its approved. While fda does provide access to drug application action packages that include all discipline reviews after a drug has been approved, thia tilt is sometimes limited by their complexity. While these new summaries provide a window into the basis for our approval decisions, theyre packaged into a format that at times can make a difficult to decipher the key Clinical Evidence. We believe by posting key portions of the csrs publicly in response will both comply with our existing obligations to make sure the summary material is publicly available on approval and make that material significantly more practical and use it friendly for key collaborators. At the same time were taking another new step to make it easier for patients and clinicians to track new therapies as they advance through Product Development and different regulatory check points. Right now the job of privately and publicly supported trials arn the world register at the National Institute of healths database. This website provides easy access to information on studies on a wide range of diseases and conditions. Ultimately some of these new conditions provide new drugs. These trial drugs are often of interest to Patient Research communities. Yet tracking a specific trial in its active state on clinical tria tria trials. Gov can be very challenging at times. In response we plan to increase transparency around Clinical Research posted on clinical tria trials. Gov will use to link fda communications about those specific drugs including in the product labeling and even in our Advisory Committee materials. This new number will be called an mct number. Members of the patient and academic and scientific communities can use this number to follow the development through key regulatory mile stones. This number will make a easier to coordinate the listings to fda communications about specific drugs including product labeling and even our Advisory Committee materials. Including this number on fdas materials could greatly benefit all those interested in following the progress of specific Clinical Research. Were also continuing to explore whether it would be possible as we discussed at the outset under existing Statutory Authority with changing the governoring law to release Additional Information from complete response letters related to the efficacy and safety that could have significant Public Health value. Releasing all csrs would be challenging with the likelihood we would continue to redact certain proprietary information from these letters. For example, many letters primarily relate to manufacturing shortcomings with new drug applics that are eventually resolved. But some of the letters do contain information that could be directly relevant to patient. Were evaluating whether theres a subset in response letters, whether theres Public Health reasons to redact and release these letters. This could include letters that have safety findings that could help with the profile of already marketed drugs. Releasing this information could enhance Patient Safety by reducing the number of potentially futile trials and spare patients exposure to potential risks without the likely benefit. Were committed to enhancing transparency throughout the work we do at fda. This is especially true when it comes to these efforts to have the potential to foster further research and discovery across the Scientific Community and clinical care. And well continue to seek additional opportunities to foster greater access to key scientific information and clarity around regulatory decisions wherever appropriate. The powerful synergy between high power data sets has been effect for over 50 years, long before the advent of the desktop commuter. Arguably two of the most important and impactful initiatives undertaken in the postwar era. In the launching of the study in 1948 and the Surgeon Generals report on smoking in 1964. Over the ensuing decades subsequent analysis new generations of participants, spouses and children helped revolutionize our understanding of the risk factors of card cardiovascular disease. The combination of better science and a better informed public led to a dramatic decline in mortality from all forms of cardiovascular disease including heart stroke, and coronary disease. The National Institute of Health Reports that the death rate from the disease peaked just before the Surgeon Generals 1964 report on smoking and started falling. From 1968 to 2010 the age of death rate from the disease has declined by nearly 70 . Today the study has expanded to include bio specimen banks. Technology no matter how powerful is always just a tool. Its our commitment to the transparent, responsible and science based use of those tools that gives them their potential to save and improve lives and build many more practical framingham studies for the 21st century based on a growing number of open sourced data tools and data sets. To reach their potential open data, and advance trial designs will all have to be validated through transparent processes that gain the trust of stakeholders. Not by inventing new values but by recommitting ourselves to fdas centurylong commitment to its Gold Standard for evaluating effectiveness and safety. Thanks a lot. Thanks for your time today. Look forward to your questions. So i think people should have index cards. And if you can put questions down there and just raise your hand with them, well collect them. And ill get them and well be able to ask questions. Im going to come over and get started. Mr. Gottlieb, thank you very much. It did not disappoint with some transparency of the news at the agency. I want to start with a general question and start with some specifics about the announcements that you made. Some people think of fda as a black box, that the agency sits out there like a white oak and makes decisions. And thats the important thing. How the decisions get made, not so important. How would you think of, whats the metaphor you would like people to think of fda . I think its very important that people understand exactly how the decisions get made and the processes that inform how we go about analyzing data, making decisions and also the values that inform those decisions. Because ultimately a lot of the decisions that we do make are policy calls. And you can scientifically define the risks and the benefits of a product related decision. But ultimately a decision on how you balance those risks against those benefits involves a lot of policy Decision Making. And i think we need to be more transparent and engage the public on how we ultimately do that balancing. And i think we do do that. I think we do a good job of that, and its gotten a lot better over time. It provides a lot of transparency. We hold a lot of public workshops. We engage the public. We try to post online guidance and through other vehicles detailed documentation on how we make those decisions. And theres more of an impetus i think than ever before for the career staff to engage the public as much as possible through speaking engagements and other kinds of workshops to articulate our philosophy. I think ultimately, though, one of the challenges we face is that the complexity of what the agency does sometimes makes it hard to access. And i think thats something we struggle with historically. And thats something that i think were trying to address through, for example, engaging patients more actively in the mechanics of the review process, trying to elevate Patient Involvement in some of the regulatory Decision Making on the Advisory Committees. But i think thats been a historical challenge. I dont think its just a question of making more Information Available. And i think the issue is how do we sort of make the philosophy and that policy balancing more transparent. Yeah, let me ask you about the csr announcement you just made, the complete study reports. These are pretty complex documents. Theyre big. They have a lot of data in them. What are the kinds of benefits do you see from this Pilot Program . I think, first of all, its going to make the review process more efficient. And were doing it as a Pilot Program, but we think over time a lot of manufacturers are going to see the inherent value of making these csr reports public. Because a lot of these memos right now are cutting and posting from the review documents and the bottom line clinical information on forms to review isnt very accessible on those documents. I think when were able to link to the csrs, the bottom line information on the csr is going to make the bottom line review document much more efficient, more accessible and could provide a lot of efficiency to the review document itself. This is part of the broader reforms under way. Were trying to come up with a more consolidated review memo. A lot of documents made public at the time of product approval are different documents related to the different consultative aspects of the review process, so different components of the agency and the consultants, so you have multiple memos. We want to work in the direction of coming up with a more consolidated memo so you have a more team based approach and everyones working together to consolidate that explains the agencys filus fae where you have one document where you can see the consensus. Having the csr available, being able to link to it makes it much more feasible to come up with a consolidated document. Just to finish, so thats one virtue of doing it. And thats sort of an efficiency. But the other is that the csr is one level above patient specific data. It is more bottom line data, and these can run hundreds of pages. I think that having it available is going to allow third parties to do more analytics around our Decision Making and do more analysis. And so youll have Research Better informed by actual data. Right now some Drug Companies release summaries of the csr, but they dont actually release the csr, so this would be the whole csr. So two questions. One, should people be worried patient level data will be disclosed or therell be approaches to making sure theres not a confidentiality so this isnt patient level data, and were very mindful to make sure, and were going to have to go through it to make sure theres no way to we saw that experiment with the kol, the way they looked at searches and were able to go to peoples homes and who were doing searches by decoupling the data. Thats a concern, obviously. You want to make sure the csr data that someone who is a researcher cant somehow correlate in a way they can get down to patient level data. And so thats one of the things were very focused on. We feel pretty confident that thats not going to be the case. The csrs are released, i dont know all the specifics around it. In europe the csrs are available but theyre not readily available. Theyre available on a proprietary database i think thats maintain bide the ema where certain researchers can get access to it. So there is some precedent for allowing certain qualified researchers access to the csrs. We want to do it on a more whole sale fashion, but starting as a pilot were working through more legal issues. Were reaching out to companies with products we think this could be particularly relevant and could allow for a more efficient process, and then well see where it goes. I do believe, whether making this voluntary or mandatory going forward, well work it out with the pilot. But i am making a pitch, and i made it at the outset for the fact i think that when you look at what ware able to do in making the csr publicly available in terms of how it changes the nature of how the review memo gets to arrive and changes how the review process works, i think people are going to see it creates a lot of efficiencies. Because the creation of that those reviewer memos and how people formulate their opinions does drive a lot of the structure of how the review process itself works. To the extent you can develop a more consolidated review opinion that more easily surfaces areas of agreement, disagreement, its all in one document, it lends itself to a more team based approach, which is the direction i want to move in which ive already talked about. Where people are part of a dawn solidated team, the memo itself needs to be a teambased effort. So in theory that would encourage more manufacturers to participate. We think its going to create a more efficient review process with greater input from people who have expertise in different disciplines. Theyre part of consolidated review team, and we think manufacturers are going to recognize thats more efficient. I see. And that would encourage. Yes. And moving onto the Clinical Trial number, which is another recommendation thats in the blueprint for transparency, so much appreciated. One question there. It has been the case that some researchers sometimes dont register their trial appropriately or dont, you know, do the linkages themselves. So obviously theres one aspect of it which is just getting the information to people so they can see where theres a trial thats been