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Washington-Watch
Scott Gottleib, MD: Company Man for FDA?
Policy experts say his ties to industry are an asset and liability
SAVESAVED
by Shannon Firth
Washington Correspondent, MedPage Today
March 13, 2017
WASHINGTON -- Scott Gottlieb, MD, is indeed President Trump's choice for FDA commissioner, according to a White House press statement, and he's getting mixed reviews from industry and policy experts.
Gottlieb is a partner at New Enterprise Associates, a venture capital fund with strong connections to the pharmaceutical industry; a resident fellow at the American Enterprise Institute, a conservative think tank; and a member of the Federal Health IT Policy Committee. He also served as FDA deputy commissioner under President George W. Bush from 2005 to 2007.
"In some ways for the Trump administration, he may be a rather traditional pick ... given some of the alternatives who had been floated,"said Caleb Alexander, MD, co-director of the Johns Hopkins Center for Drug Safety and Effectiveness in Baltimore, in a phone interview. Those alternatives included Jim O'Neill, a libertarian and a strong supporter of "progressive approval," or allowing drugs to be approved based on safety before their effectiveness has been established, according to Forbes.
Gottlieb's views on speeding up the review of generic products, and increasing generic competition, have been well-received, Alexander said, adding that Gottlieb's extensive industry experience is both "an asset and a liability." He noted one handicap that Gottlieb shared with Robert Califf, MD, the current commissioner.
"The depth of his expertise in tobacco and food is invariably going to lag behind his knowledge of medical products, and the FDA regulates all three," he noted.
'A Committed Reformer'
In an email to MedPage Today, Kip Piper, a healthcare reform consultant for Sellers Dorsey, called Gottlieb "an articulate advocate of increased patient access to innovative medical therapies and technologies," and "a committed reformer who can get the job done "
Piper and Gottlieb worked together as senior advisors to the administrator for the Centers for Medicare and Medicaid Services under President George W. Bush.
"Dr. Gottlieb's strong scientific base and understanding of programs, such as the breakthrough therapy designation and Oncology Center of Excellence, can help the FDA continue to streamline its processes," said Jeff Allen, PhD, president and CEO of Friends of Cancer Research. "Through his knowledge and experience, we have no doubt that Dr. Gottlieb will be the right person to ensure the FDA keeps pace with science and innovation without sacrificing the safety and efficacy gold standard established by the FDA."
In a survey of pharmaceutical executives from Mizuho Securities USA, given the choice of four potential candidates to run the FDA, including O'Neill, 72% chose Gottlieb, according to EndPoints News.
"Our industry applauds Dr. Gottlieb's commitment to innovation in medical technology and his recognition of its important role in providing the best care possible for patients, said Scott Whitaker, president and CEO of the Advanced Medical Technology Association (AdvaMed) in a press release. "Specifically, we look forward to working with Dr. Gottlieb and his team on the medical device user fee reauthorization in the coming weeks and months in our mutual pledge to continued patient access to life-changing technologies."
Stephen Ubl, president and CEO of PhRMA, lauded Gottlieb's experience, both as a physician and healthcare expert, in a press statement.
Complicit with Pharma?
Susan Wood, PhD, associate professor of health policy and management at the George Washington University Milken Institute School of Public Health in Washington, was less enthusiastic.
Any FDA commissioner must have the strength to stand up for the agency, and resist the "politicization" of its decisions, stressed Wood, a former FDA assistant commissioner for women's health, who was at the FDA at the same time as Gottlieb.
"It's widely known that he's very conservative; that he's been sympathetic, if not complicit, with the pharmaceutical industry over many years, and so that raises some concerns," she noted. Wood said she had two main questions about Gottlieb -- how would he withstand industry pressure, and how would he withstand political pressure?
As for access to reproductive products, including contraception or abortion medication, "the question is will he stand up to political pressure, not just on behalf of the FDA, [but] on behalf of people in the United States who depend on the FDA making its decisions based on science and on good medicine," Wood asked.
Diana Zuckerman, PhD, president of the National Center for Health Research, stated that Trump could have made a worse decision. "Gottlieb understands the agency and his goal will not be to destroy it," she pointed out.
However, because of Gottlieb's "enormous" conflicts of interest with industry, Zuckerman said she is not entirely comfortable with his selection.
She noted that the FDA of late has allowed drug approvals based on "skimpier research ... If Dr. Gottlieb continues [with] the FDA on this path of lowering standards, insurance companies will do what they've already started to do, which is to say, 'We're just not going to automatically cover FDA products, because too many of them are being approved without proof that they worked.'"
Consumer watchdog Public Citizen also expressed disappointment in the choice.
"When Gottlieb served as FDA deputy commissioner, he was recused from many key meetings and decisions due to his close relationship with industry. If the Senate does not reject Gottlieb, he will have to be recused from key decisions time and time again, otherwise there is no way to be sure he will put the public's health over industry profits," said Michael Carome, MD, director of Public Citizen's Health Research Group in a press statement.
Carome expressed concern that Gottlieb cares more about getting medications to market quickly, than he does about safety and efficacy. "Gottlieb's appointment would accelerate a decades-long trend in which agency leadership too often makes decisions that are aligned more with the interests of industry than those of patients. The Senate must reject the nomination and demand a nominee who is better suited to protect public health," according to the statement.
The Senate is expected to schedule a hearing to discuss Gottlieb's nomination.
Next: House GOP's ACA Replacement Bill: What's In, What's Out?
Great post!
I suspect the FDA didn't bother with the ADCOM because they knew they were issuing ELTP the CRL. Assuming we can get to the point were we can successfully address the items outlined in the CRL, the FDA may very well grant us the ADCOM.
I appreciate your honest/no b.s. perspective. I hope you stick around for a while.
One of your new followers.
The app didn't go number 1, a music video which contained the app went number 1. Big difference.
Interesting timing. So much more going on behind closed doors than we can imagine.
Happy retirement...
Ms. Ellison retired from the Company, effective June 1, 2016 and is no longer an employee of the Company. As of the date of Ms. Ellison’s retirement, the options issued to Ms. Ellison were not fully vested, with 400,000 shares being vested and 200,000 shares being non-vested. Pursuant to the 2009 Employee Stock Option Plan, vesting of options require that the employee holder of such options be employed by the Company on each vesting date. Accordingly, future vesting of the non-vested option to purchase 200,000 held by Ms. Ellison at the time of her retirement’s retirement is prohibited. The vested options to purchase up to 400,000 shares at a price of $0.33 per share expire 90 days from the date of termination of Ms. Ellison’s employment with the Company, pursuant to the 2009 Employee Stock Option Plan.
This is from the 10k last year...
NOTE 25 CONTINGENCIES
As part of the Company’s efforts to ensure the retention and continuity of key employees, officers and directors in the event of a change of control of the ownership of the Company, the Board of Directors passed a resolution whereby, in the event of a change in control of the ownership of the Company, key executives would receive an amount equal to twelve months of such executive’s salary, and certain Directors and managers would receive an amount equal to six months of such Director’s or managers fees or salaries, as applicable. In addition, the resolution passed provided for the immediate vesting of outstanding options, in the event of a change of control.
NOTIFICATION OF LATE FILING
L2 showing a lot of resistance @ .36. Let's see if we can blow by this point of resistance.
Davis Caskey's bio just added to the website
http://www.elitepharma.com/board-of-directors/
ELTP Due Diligence Report: Quiet on the Press Release Front; but Surge Continues
http://broadstreetalerts.com/wp-content/uploads/2016/06/analyst-report-ELTP-ihub-bsa.pdf
You're an optimist...I like that. And I have to tell you it's contagious.
Enjoy your Sunday.
Lasers, although familiar with CINV I don't tend to see it in my practice.
Unfortunately not. Here's an example of the FDA announcing a delay with only 48 hours left before the anticipated PDUFA date.
http://phx.corporate-ir.net/phoenix.zhtml?c=115565&p=irol-newsArticle&ID=2129570
Regardless of why it was delayed, it shows that the FDA is on it's own schedule. Let's just hope they approve SequestOx by July 14th or before.
Pfizer's Troxyca Gets Mixed Review From FDA Advisors
Oxycodone/naltrexone combo meets current safety standards, but is that enough?
author name
by Kristina Fiore
Associate Editor, MedPage Today
A joint FDA advisory committee gave a tepid endorsement (9-6) to extended-release oxycodone/naltrexone (Troxyca) for treating severe pain, but such close votes are often considered "null" among FDA observers.
In separate votes, the committee voted in favor of abuse-deterrent labeling for the intranasal (11-to-4) and intravenous (9-to-6) routes of abuse, but against language that it prevents oral abuse (6-to-9) for the drug, formerly known as ALO-02.
Many panelists who said "yes" to approving the drug said they did so based on a "narrow" reading of the indication, and the current standard of approval for extended-release and long-acting opioids.
"It was demonstrated to be as safe and as effective as our current standard, but evidence points to this class of drugs not being safe or effective for chronic pain in general, so I wasn't comfortable voting "yes" for this product," said Melinda Campopiano, MD, of the Substance Abuse and Mental Health Services Administration (SAMHSA), who voted against approval.
"I agree that it meets the current standard, that it is no less safe or less effective. But that current standard is what brought us the opioid epidemic we are dealing with," said Tobias Gerhard, PhD, of Rutgers University in New Brunswick, N.J., who also voted against approval. "We have to start making changes at some point."
The two committees -- the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and the Drug Safety Risk Management Advisory Committee (DSaRM) -- met 2 days in a row to consider two new extended-release opioids that were hoping to win abuse-deterrent labeling.
On Tuesday, they gave a hesitant vote in favor of Teva's hydrocodone drug Vantrela. But during both meetings, panelists generally agreed that the criteria for awarding abuse-deterrent labeling have to be better defined, and that putting additional extended-release opioids on the market may not be the best thing for public health at this time.
"We've heard over the last 2 days -- and it's beginning to be repetitive -- a drumbeat for limiting the number of long-acting/extended-release drugs on the market," said Raeford Brown, MD, of the University of Kentucky in Lexington. "We worry constantly about our ability to make the right decision -- which we all want to do -- without being able to see the post-marketing data."
"Again I'm going to ask the agency to make some concerted effort to get those data out so we can begin to know if the decisions we're making are the right decisions," Brown said.
Panelists noted that this meeting was unique in that Pfizer has a similar product, Embeda, on the market that uses the same technology. It involves a capsule of tiny beads that package the opioid around a core of naltrexone, a potent opioid antagonist, in hopes of reducing abuse.
Embeda combines morphine and naltrexone, while Troxyca would combine oxycodone and naltrexone. The idea is that patients who have trouble swallowing could open these capsules of beads and spread them on food -- something that couldn't be done with many other forms of abuse-deterrent opioids.
Embeda didn't receive abuse-deterrent labeling when it was approved in 2008, but the FDA did award such labeling in 2014.
Sharon Hertz, MD, director of the FDA's division of anesthesia, analgesia, and addiction products, said the labeling wasn't awarded in 2008 because the agency didn't have any guidance on abuse-deterrent labeling at that time.
"We did not know at the time what to do with them," Hertz said. "As a result we opted not to label -- not because we decided it was good or bad."
Post-marketing studies on Embeda are due in 2019, but no interim data were available -- a major complaint of the panelists, who continued to point out that there is no evidence that any opioid with abuse-deterrent labeling actually reduces abuse.
"This technology is already on the market," Campopiano said. "We have the opportunity to make a better informed decision if we wait for that postmarketing data."
Panelists were also concerned that the drug, while resistant to abuse via crushing and several types of dissolution, appeared to be easily dissolved in three commonly available solvents that are safe for consumption and easy to obtain, although it might take some time to do so.
"Once the recipe is out there, it doesn't matter if they had 5,000 data points that didn't work," said panelist Jeanmarie Perrone, MD, of the University of Pennsylvania in Philadelphia. "Once you get the one that does work, it will be the one that proliferates, and it's pretty simple based on what we've looked at."
Michael Sprintz, DO, of the Sprintz Center for Pain and Dependence in The Woodlands, Texas, said that while the extra time might deter some potential abusers, it won't deter operations looking to produce the drug at scale.
"We have to think about the real world, which is not just abuse, but also diversion, which creates a market for addiction," Sprintz said. "We have people who may be doctor shoppers or drug diverters with the intent to sell."
Perrone also mentioned that the highest dose of the drug -- 80 mg twice daily -- would be in excess of limitations recommended by recent CDC guidelines on opioid prescribing.
Six ER/LA opioids have abuse-deterrent labeling: OxyContin (oxycodone), Targiniq (oxycodone/naloxone), Embeda (morphine sulfate/naltrexone), Hysingla (hydrocodone), Morphabond (morphine sulfate), and Xtampza (oxycodone).
It's not clear when post-marketing data from these abuse-deterrent formulations with regard to how they impact abuse, addiction, overdose, and death will be available.
Gerhard noted that abuse-deterrent labeling could give patients and physicians the wrong impression: "If prescribers think it's safer and that patients are less likely to get addicted, none of this has been shown with any data. We have to be very careful granting that status."
LAST UPDATED 06.09.2016
0 COMMENTS
Informative post. Thank you.
5. VOTE: If approved, should Troxyca ER be labeled as an abuse-deterrent product by the intravenous route of abuse? $PFE
9-Y
6-N
0-Abstain
From the chair of the Adcom
https://pbs.twimg.com/media/Ckc6sr2XIAAyaEv.jpg
4. VOTE: If approved, should Troxyca ER be labeled as an abuse-deterrent product by the nasal route of abuse? $PFE
11-Y
4-N
0-Abstain
3. VOTE: If approved, should Troxyca ER be labeled as an abuse-deterrent product by the oral route of abuse? $PFE
6-Y
9-N
0-Abstain
2. VOTE: Should #Troxyca ER be approved for the proposed indication? $PFE #opioid
9-Y
6-N
0-Abstain
Just leaving the OR now, not sure how far along they are. If I can I certainly will.
Nice...its been a while
I listened to the webcast live. As soon as there's something in print, I'll be happy to post it.
#Vantrela AdComm vote for intranasal abuse-deterrence claim - Y- 14, N -3
#Vantrela AdComm votes 14-3 for abuse-deterrence claims for oral abuse
2. FDA AdComm VOTE: Should #Vantrela ER be approved for the proposed indication? $TEVA
14-Y
3-N
0-Abstain
Teva's opioid not abuse-deterrent when taken orally: FDA staff
http://www.foxnews.com/health/2016/06/06/tevas-opioid-not-abuse-deterrent-when-taken-orally-fda-staff.html?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+foxnews%2Fhealth+%28Internal+-+Health+-+Text%29
I contacted the FDA to try and obtain more information on when was the latest they could notify ELTP concerning an ADCOM meeting. They replied the following, most information has already been shared on this board, but I thought I'd post it anyway. I hope some of you find this useful.
Dear Dr. ___________,
Thank you for writing to the Division of Drug Information, Small Business and Industry Assistance (SBIA), in the FDA's Center for Drug Evaluation and Research.
For more information about the review timeline, please refer to Guidance for Review Staff and Industry, Good Review Management Principles and Practices for PDUFA Products, http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm079748.pdf.
Please note that the FDA will not confirm an Advisory Committee meeting until publication of a Federal Register (FR) Notice. To view FDA Federal Register Notices and new publications of Federal Register Notices, please see the following website: http://www.fda.gov/RegulatoryInformation/Dockets/FR/default.htm.
Under the PDUFA provisions, submission of a major amendment during the last 3 months of a review may trigger a 3-month extension of the review clock. The Agency decides whether to extend the review clock in response to such amendments. This decision is based on a variety of factors (e.g., content of the amendments, FDA workload and resources, existence of other known deficiencies that may affect approval and have not been addressed by the amendment), but the underlying principle is to consider the most efficient path toward completion of a comprehensive review that addresses application deficiencies and leads toward a first cycle approval when possible.
Additional information about factors the FDA considers in deciding whether to refer a matter to an advisory committee for consideration can be found at http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM125651.pdf.
You may also find information found at the following links useful:
Regulations governing the advisory committee can be found in 21 CFR Part 14 at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=14;
Common Questions and Answers about FDA Advisory Committee Meetings, http://www.fda.gov/advisorycommittees/aboutadvisorycommittees/ucm408555.htm.
We hope the information provided is helpful.
Best regards,
AA
Drug Information Specialist
CDER Small Business and Industry Assistance
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration
It hasn't been posted yet. I'll share it with the board once it is.
It'll be posted on pinneyassociates.com if you're interested in keeping an eye out for it.
Nas, as a follow up to yesterday's discussion. I've received a response and the webinar is still being edited and will be posted upon it's completion.
I'd post the actual reply but statements like the following preclude me from doing so.
"you are hereby notified that any distribution or copying of this communication is strictly prohibited."
Nas, as you can see below the recording is apparently available (upon request as I can't seem to find it) at several sites. I've emailed PinneyAssociates for access to the webinar. If I obtain it, I'll be happy to post it.
For more information and to register for the webinar, click here: Registration. Availability will be limited. Please register by Friday May 20, 2016. The webinar will be recorded and available for on-demand viewing at the DrugScan, PinneyAssociates, and INC Research websites.
Thank you. As always, I appreciate your expertise.
In the following example it seems the company submitted information after the fact resulting in an amendment of the NDA. As far as we know this isn't the fact with Elite and SequestOx.
Again don't get me wrong, I want approval as much as you...it's been a long five years.
http://www.businesswire.com/news/home/20160208005533/en/Sarepta-Therapeutics-Receives-Notification-PDUFA-Extension-Eteplirsen
Enjoy your long weekend.