Latest Drugwonks' Blog
I’m in Riyadh, Saudi Arabia where I just spoke at the first Saudi Quality Forum (sponsored by King Saud University). I also had the opportunity to meet with the leadership of the Saudi Food and Drug Authority (SFDA) -- which is also the national reimbursement agency. (And no product gets licensed without first concluding price negotiations.)
And you thought FDA swings a big stick.
My suggestion to their executives is that they form an Office of Policy and Planning – and that one of the first items on the agenda be chairing a regular meeting of industry (both innovator and generic) and academia to address issues of common interest including API and excipient quality, biosimilars (specifically the issues of biosimilarity and interchangeability), 21st century pharmacovigilance, generic interchangability, and other issues that fill the Arabian regulatory gulf -- like re-registration.
The SFDA aspires to be not only the gold standard for the region, but also a world-class regulatory agency. But to do so they must recognize their responsibility to be both regulator and colleague to industry and an innovation enabler. Sound familiar?
My favorite sound-bite from the conference came courtesy of the SFDA’s Mohammed Dahhas (Executive Director of Inspection and Law Enforcement, Drug Sector): On the issue of quality by design, “Quality is the magic key.”
My favorite new concept came from Accenture’s Pierre Anhoury, who introduced the conference attendees to notion of “value vigilance” – a new way to view post-approval value-based reimbursement via pharmacovigilance, quality of life, therapeutic benefit, and pharmaco-economic impact. Maybe we should call it Phase 4.1.
(Have a look at Anhoury’s new white paper on the topic, Approval is Nothing: Why Pharmaceutical Companies Need a Value Management Operating Model.)
Wouldn’t it be NICE to bury the QALY in the sands of Saudi?
"We are thankful to all of you who have prayed for Michal and expressed your support in other ways. Here is another opportunity for those interested.
On March 3, 2013 both our sons-in-law, Ben Coleman (Michal’s husband) and Sean Wasserman, will be participating in Cycle for Survival, the national, indoor team cycling event that has raised more than $20 million in support of life-changing research on rare cancers at Memorial Sloan-Kettering Cancer Center, one of the world's premiere cancer research institutions.
100% of the funds raised through this ride go directly to MSKCC's research of rare cancer, like Synovial Sarcoma, making us feel very personally connected to this cause. With your help, we can move closer to finding out how to cure cancers like the one Michal is battling right now.
The 2012 ride donations were already put to work in twenty-eight different MSK labs and clinics – targeting a wide range of rare cancers. This progress – and the hope it brings to patients and their families – is only possible because of thoughtful contributions from people like you! We are asking you to join the battle and make a gift to support our ride against cancer. The link below will bring you to our fundraising page, where you can make a tax-deductible online donation."
http://mskcc.convio.net/site/TR/CycleforSurvival/AG_Cycle_Event?pg=team&fr_id=1818&team_id=26100
How many times have you read, “The FDA is not required to follow the advice of its advisory panels but usually does."
Except when it doesn’t.
Recently an agency advisory panel voted against recommending making oxybutynin transdermal patch (Oxytrol) available over-the-counter (OTC) for overactive bladder (OAB) in women.
In their 5-6 vote, panelists on the FDA's Nonprescription Drugs Advisory Committee noted their concerns that women would use Oxytrol thinking they had OAB when they really had some other ailment that needed a physician's treatment. They also were concerned about men using the product off-label.
Some also were worried about the high amount of potential misuse -- whether it was by patients who did not have indications for proper use, or those it was meant for that didn't use the product correctly.
Well, today the FDA ruled that a patch containing oxybutynin (Oxytrol) for controlling overactive bladder may be sold over-the-counter for women 18 and older.
Men will continue to need a prescription for the drug, the agency said. The OTC product will be marketed by Merck as Oxytrol for Women.
In considering an Rx-to-OTC switch, the FDA looks to see whether patients can use the product safely without the oversight of a physician or pharmacist. This includes ensuring that the right patients use the drug in the appropriate way ("safe use"). The agency is not evaluating the risk-benefit of the product, since that was done earlier when it was approved as a prescription drug.
But, considering all of the issues surrounding this particular switch (conditions can cause symptoms similar to those of OAB, including urinary tract infection, bladder malignancy, pregnancy, prostate disease, and uncontrolled diabetes mellitus), AdComm panelists (who voted no) said those conditions need a physician's care, and an OTC oxybutynin could delay treatment. Shouldn’t the FDA have asked Merck for a “safe use” plan – in addition to the age restriction? Sort of REMS for OTC products?
Note to FDA – there’s an app for that.
Drug companies and medical-device makers would be forced to publicly disclose any money paid to doctors under new U.S. regulations designed to make patients aware of conflicts of interest that may affect their health.
According to CMS, the Sunshine Act’s final rule will be released “soon.”
Expanded public disclosure, according to an interesting Bloomberg article is likely to focus greater scrutiny on physicians serving on FDA advisory panels.
Doctors who now sit on FDA advisory panels must inform the agency about conflicts of interest. The FDA determines when a waiver for a financial conflict may be necessary and otherwise keeps arrangements between doctors and companies secret, even from other panel members.
Peekaboo, Sid Wolfe sees you.
PMLive reports:
Pharmaceutical companies may have enthusiastically embraced Twitter, at least at a corporate level, but local European regulators have proved somewhat more reticent.
The European Medicines Agency (EMA) led the way by signing up to the social network in 2010, but few local bodies have followed suit.
One of those that did was the Medical and Healthcare products Regulatory Agency (MHRA), and the UK regulator has just expanded its use of Twitter and launched three new accounts on the social network.
One of these is a corporate account, the use of which tends be pharma’s first step into social media.
The MHRA says its new corporate Twitter presence, @MHRAgovuk, will be used to promote general information and updates, while two other accounts will focus on safety alerts and information about medical devices and medicines.
The regulator has been cautious in its approach to Twitter to date, launching dedicated accounts in 2011 for first herbal remedies and then its press office, the account names of which have been simplified as part of its Twitter expansion.
It remains to be seen how well the use of separate accounts for press and corporate purposes will work, given the potential for subject overlap between the two.
But the use of new, separate accounts for medicines and medical devices seems logical, given the differences in audience for a recall of Merck Sharp & Dohme’s Tredaptive versus that for a mass spectrometer.
• Links to all of the MHRA's Twitter accounts, and many more from regulators, industry associations and pharma companies, can be found in the Twitter section of the Digital Handbook’s pharma social media directory
The Drug Enforcement Administration has once again asked the FDA to consider tightening prescribing and other rules on hydrocodone drugs.
Proving, once again, that the DEA doesn’t understand the problem. Denying access to patients in pain (the unintended but obvious consequence of up-scheduling) does nothing to stop those who provide hydrocodone – via inappropriate prescribing or illegal means.
The FDA will hold hearings tomorrow and Thursday to consider whether to move hydrocodone products from schedule III to the more highly regulated schedule II class under which narcotics such as OxyContin (oxycodone) fall. In a briefing document released as background material, FDA scientists said that although "patients taking hydrocodone products might develop moderate or low physical dependence, they would not be expected to develop addiction."
This is regulatory-speak for not wanting to change the classification.
CDER Deputy Director Dr. Doug Throckmorton said an analysis conducted internally by scientists at the agency does not reflect the FDA's "official stance." He said the agency will refrain from making recommendations until after it has reviewed testimony and received a recommendation from the independent advisory committee, which scheduled the two-day hearing.
This is regulatory-speak for, “we know what we want to do – but we want to solicit informed opinion."
Please step up to the microphone and state your name.
FDA said in a statement that the government decided not to seek further review of a December decision that found that the federal government could not prosecute a sales representative for speech promoting the legal, off-label use of an FDA-approved drug. According to the statement, the agency does not believe the 2-1 decision from the U.S. Court of Appeals for the Second Circuit in United States v. Caronia "will significantly affect the agency's enforcement of the drug misbranding provisions" of the Food, Drug and Cosmetic Act (FDCA). FDA added that the decision "does not strike down any provision [of FDCA] or its implementing regulations, nor does it find a conflict between the act's misbranding provisions and the First Amendment or call into question the validity of the act's drug approval framework"
Surprised? Don’t be. Whenever the FDA goes to court on First Amendment issues it either loses or gets a stern rebuke for its unpredictable, ambiguous and sometimes capricious application of off-label speech constraints.
Regardless of the FDA’s decision, Caronia will impact the way FDA views off-label promotion within the context of the free-and-fair dissemination of scientific data. I believe a new (and hopefully more enlightened) FDA view based on intent will arise. Alas, that will not assuage any of the ambiguity that is currently driving FDA (OPDP) communications oversight. That being said, any revisitation and discussion is for the better.
Some believe that, if Caronia stands, pharmaceutical companies will no longer feel obligated to seek FDA approval for new indications, since they can openly "promote" them without fear of prosecution. This is a flawed argument. Indications of the on-label variety have many benefits—not the least of which is reimbursement. But such negative unintended consequences are important to discuss and consider. IMHO, any company that chose this route would be acting in a highly irresponsible manner, putting promotion before the public health.
“See you in court?” Not likely.
From: A Message from the Commissioner
Sent: Tuesday, January 22, 2013 10:54 AM
To: FDA-Wide
Subject: Personnel Announcement for the Office of Medical Products and Tobacco
Dear FDA Colleagues:
I wanted to make you aware of the upcoming departure of Dr. Stephen Spielberg, Deputy Commissioner for Medical Products and Tobacco. Due to a family medical issue, Dr. Spielberg will be leaving FDA on February 15 to return home to the Philadelphia area. In March, he will assume the role of editor-in-chief of “Therapeutic Innovation and Regulatory Science”, a new journal launched by the Drug Information Association.
For the past year and a half, Dr. Spielberg has been a terrific spokesperson for the Agency and a key member of my senior management team, supporting the invaluable work performed across the Centers for drug, biologics, medical devices, and tobacco products and the Office of Special Medical Programs. He has been an important partner in helping the agency toward a more integrated approach to medical product evaluation across the Directorate, in working together with Center leadership to address the rapid changes in human biology and therapeutic interventions, and in helping optimize FDA’s approach to evolving areas such as personalized medicine.
We will miss the leadership and wise counsel he has provided during his time at the agency.
I am pleased to announce Leona Brenner-Gati, MD, has graciously agreed to serve as Acting Deputy Commissioner for Medical Products and Tobacco. Dr. Brenner-Gati is currently the Associate Commissioner for Medical Products and Tobacco and comes with twenty years of experience in the private healthcare sector, where she has focused on emerging technologies and complex product development. She has extensive experience leading multi-disciplinary, cross-functional teams spanning pharmaceuticals, devices, diagnostics and consumer sectors, and has applied highly integrative scientific and administrative expertise to foster the development of groundbreaking medical products.
Dr. Brenner-Gati spent seventeen years at Johnson & Johnson, where she held senior leadership positions in Science and Technology, Clinical Research and Development, Global Project Management, Medical Affairs, and Business Development in the Pharmaceuticals and Medical Devices & Diagnostics Groups and Corporate Headquarters As a champion of Regenerative Medicine product development and initiatives, she founded J&J’s cell therapy for diabetes program, and chaired the Scientific Advisory Board and served on the Management Board. She was also Vice-Chair of J&J’s Human Pluripotent Stem Cell Committee, helped found and served as an officer and board member of the Alliance for Regenerative Medicine, and was a member of the FDA/California Institute of Regenerative Medicine Roundtable on Regenerative Medicine. Prior to J&J, Dr. Brenner-Gati led the Internal Medicine Clinical Research Therapeutic Area at Sandoz Pharmaceuticals and achieved successful registration of several products.
Dr. Brenner-Gati graduated from Princeton University, magna cum laude in Biology, Phi Beta Kappa, and received her medical degree from Harvard Medical School. She obtained her postgraduate medical training at New York University/Bellevue Hospital Medical Center, and held academic appointments at Cornell University Medical Center/New York Hospital, where she performed basic science and clinical research, taught medical students and had a medical practice. While at Cornell, Dr. Brenner-Gati was a clinical investigator for seven years in the landmark NIH Diabetes Control and Complications Trial. She is board certified in Internal Medicine and Endocrinology & Metabolism and holds medical licenses in New York and New Jersey.
Please join me in extending a warm welcome to Dr. Brenner-Gati as she takes on this new role, and please join me in thanking Dr. Spielberg for his significant contributions to our public health mission.
Sincerely,
Margaret Hamburg, MD
Commissioner for Food and Drugs
Year, n. A period of 365 disappointments. – Ambrose Bierce
What role will FDA Commissioner Peggy Hamburg play in 2013?
Perhaps a better question is what role will the White House permit her to play?
Since the Plan B controversy things have been pretty quiet over at White Oak. But, post-election, things seem to be heating up – in a good way.
Enrichment trials. New review pathways. A record number of approvals. Yes, 2013 could be a very good for the FDA … if Peggy is allowed to set her own course and stick to it.
And then there’s the question (often posed but rarely addressed) of the many senior players at the agency nearing retirement.
Succession plans, anyone?
The good news is that, with a firm hand at the wheel and the authority to make tough and noble decisions, good things can happen.
Future, n. That period of time in which our affairs prosper, our friends are true and our happiness is assured. – Ambrose Bierce
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
