http://www.fiercebiotech.com/special-reports/influentials-2015-dr-robert-califf-fda

Still some suggest his background may make him a little too cozy with industry. One of those is Diana Zuckerman, president of the National Center for Health Research, who Time magazine recently quoted as saying that while Dr. Califf is "a very accomplished, smart physician," his ties to industry might make some wonder about his "objectivity and distance."

So what all is on his curriculum vitae? He has rich experience in clinical research as the founding director of the in-house CRO, Duke Clinical Research Institute, which has about 1,000 employees and conducts about $320 million in research annually, at least half of that paid for by the industry. He is considered an expert in translational medicine, having run the Duke Translational Medicine Institute, which works with the National Institutes of Health to turn lab discoveries into actionable medicines.

He has also seen action from the business side of the line. He led the 6-year IMPROVE-IT study, from which the positive outcomes of Merck's ($MRK) Zetia are expected to pave the way for approval of PCSK9 inhibitors. The meds, which help statin-intolerant patients lower their bad cholesterol, are expected to grow into a $10-billion-a-year market. Amgen ($AMGN), Pfizer ($PFE) and a partnership of Sanofi ($SNY) and Regeneron ($REGN) are all playing in that field. His ties to the Merck drug could raise some eyebrows when competitors come looking for approvals.

Califf was also a member of the board at Portola Pharmaceuticals ($PTLA), a biotech working on antidotes to next-generation anticoagulants, but resigned that position to serve at the FDA. What the 63-year-old Califf didn't give up, however, is his tie to Duke, where he most recently was vice chancellor of clinical and translational research. Instead he is taking a leave of absence from the school where he has been for 33 years. Showing his pragmatic side, the doctor observed in a call with reporters when he was named to the FDA that with a new occupant taking up residence in the White House in 2017, he might yet need someplace to land.

i am sure he will be completely unbiased towards the industry he is so close with


how long before hillary comes out and says he is the wrong person for the job?

charter

there are 11,000 pesticides on the market that are either untested or undertested, yet they're allowed to be manufactured and distributed. What does this doc have to say about THAT? Got cancer/Parkinson's/etc?

responsibility of the FDA which isn't prices

while it's true that the prices have become outrageous, we know there's a lot of pressure to bring new products to market and use them off label in as many different ways as possible to maximize profit. And based on recalls, lawsuits, and some of the new black box labeling the makers had to institute after they were already on the market,we also know that mistakes are made whether intentional or not in terms of determining safety. I don't want somebody in that position who's been cozy cozy with the drug companies and has probably gotten research money from drug companies to do some of their own research. It gives me the willies.

if he did, and he might as the conversation goes along. but we all know about the collusion that goes on with government officials and big ag, big pharm, etc. in this case, it could affect safety as well as prices if they mess with generics.

no matter how we slice it, this is a bad pick, and i am glad he is highlighting it. this is the kind of influence we need to get out of health, food, and consumer safety decisions.

its a bad pick, so i think bernie is doing the right thing.

just curious, is this someone you would like to see go forward? clearly "qualified" technically, but what do you thhink of the record and pharma ties?

he shouldn't oppose the nomination on grounds of prices of drugs. The FDA doesn't have the authority. Opposing on grounds that he believes the candidate is too cozy with pharma, and may result in approval of drugs based on conflicts of interest, is a valid point. Not the prices of drugs. That is under the authority of the FTC, Congress, and perhaps health and human services

that as a senator, he knows a few things that we do not yet know. will have to agree to disagree on the price issue...if the fda and its pharma buds screw with generics, patent expiration, or prices, it becomes a safety and access issue and relevant for criticism imo

he will probably get the job anyway.

nomination, and it has nothing to do with drug prices, which is NOT under the authority of the FDA, and a responsibility that the OP incorrectly suggests it is, from both Senator Sanders, and the Washington Post

The FDA does NOT have authority over drug prices:

"The FDA has no legal authority to investigate or control the prices charged for marketed drugs. Manufacturers, distributors and retailers establish these prices."

Its authority is concerned with safety:


http://www.drugwatch.com/fda/

It may be a good sound bite to say the FDA is responsible for something it isn't, "commitment to lowering pharmaceutical prices", but it is not accurate information.

The FTC, Health and Human Services, and Congress would be the correct places for that.

If he is going to oppose, he should at least give a valid reason on which the FDA is responsible for, such as safety, not something the agency does NOT have the authority for.

Obviously, the Washington Post is just as ignorant as it appears others are of the FDA function

There is only one post so far in this thread that states a valid reason for someone to oppose the nomination, and it has nothing to do with prices. The accusation that the nominee is a little too cozy with the industry, which implies that drugs may get approved that shouldn't or shouldn't without appropriate warnings, or black box labels.

manufacturers and the real research on drugs that takes place under Federal agencies such as NIH. NIH actually pays for much of the drug research, clinical testing, through it grants and contracts.

If a drug is developed with such monies the scientists are permitted to patent what they developed, license it and there goes your pricing... It wasn't always that way but you know how smooth lobbyist and politicians can be. The Tech Transfer laws and regs put this into place. Still the drug companies scream about the high cost of research and development but that is only because they pad the salaries and benefits for their "researchers." It's a very complex system that has been set up so that average tax payers roll their eyes and suck it up, not understanding what is actually going on.

the reason for opposing the nomination was because of drug costs, he should reconsider that reason, since the FDA does not control drug prices.

Vioxx is a perfect example where its approval should have been more restrictive, and its approval without appropriate safeguards suggested not only a conflict of interest of certain members of the FDA with Merck. Also, the clinical trial data was faulty, and misrepresented the safety of such drugs, which incidentally also brought into light safety concerns of non-steroidal anti-inflammatories

It is potential conflicts of interests of an FDA appointment with pharmaceutical company, or food additive that is a valid concern to not approve an FDA appointment.

Aspartame is an example of a controversy involving the FDA and a conflict of interest. In converse, the banning of cyclamates based on questionable data also indicates a conflict of interest of which the FDA was involved with.

The question comes down to should FDA Advisory Committee members be allowed to have financial conflicts of interest regarding the medical product they are recommending for approval (or recommending against approval)?

Not hearing a word about that, which relates to safety of our food.

makers of generic drugs have to obtain fda approval (for safety) before marketing those drugs. if someone in a high-level position at the FDA is very cozy with drug companies, it is certainly conceivable that they would make the generic approval process more lengthy and difficult in order to protect a friend who might be profiting off of the brand-name version. So that is just one instance in which the FDA could have a huge effect on prices and peoples ability to get the medication they need.so Bernie's correct.

edit to add..One of the problems we've had with drug availability for people struggling financially is the stranglehold some drug companies have over there patents and the inability to legally produce generic versions. I would want to hear more detail on Bernie's reasoning, but I wouldn't be surprised if this is the kind of thing he's worried about, especially since he's known for taking people into Canada to get drugs they couldn't afford to buy here.

equivalency and safety and the trials justify it, it will be approved

The bigger issue is approval of drugs that may be fast tracked because of conflicts of interest

which could result in both cost and safety concerns.

re the tpp and pharms

http://www.democraticunderground.com/10141229206#post10

truth to power.

Win, Bernie, Win!

his opponents will correctly point out the FDA doesn't set the prices.

Earlier:http://www.democraticunderground.com/10027218409

He should nominate people who are known for their good work in non-profits at the very least

He is a self-described 1980's style Reagan Republican with a slightly left of center social compass. He follows the tenets of neoliberalism and loves the marriage of Wallstreet and DC.

There is nothing odd about yet another corporate hack high position placement with Obama.

It is verifiable fact.

the prices of generic drugs would surely drop.

Instead, generic drug manufacturers, as well as all other drug manufacturers, are gouging US citizens.

http://www.medpagetoday.com/MeetingCoverage/AMA/52031

...

Here at the American Medical Association's annual meeting, the House of Delegates rolled five resolutions aimed at curbing addressing skyrocketing generic drug prices into one new policy that directs the AMA to seek help from the FDA, Federal Trade Commission, and the Generic Pharmaceutical Association, and to "encourage the development of methods that increase choice and competition in the development and pricing of generic prescription drugs."

...

Solutions, several doctors argued, won't be easy because there is too much money on the table. "PBMs [pharmacy benefits managers] don't lose in this situation," John S. Antalis, MD, a Georgia delegate said. "I'll give you an example: lisinopril for 1,000 [mg] has doubled from $507.50 to $1,053 in 5 years."

Antalis also referenced doxycycline, an antibiotic that went from $70 for 50 capsules to $276. "They're taking money from healthcare plans, taking money from patients, more importantly."

...

"With some very important cardiovascular drugs, there's just egregious raising of prices," Steven Hao, MD, speaking on behalf of the cardiovascular section. "And just because of market share, not due to any problems with manufacturing the drug or supply. Isoproterenol was made by Hospira, the only U.S. manufacturer, and was $44 per dose in 2013. They sold the drug to Marathon and over the next year, Marathon increased it to $218 per dose," Hao said. Hao noted that this incident led to a Congressional inquiry, spearheaded by Senator Bernie Sanders. When called to testify before the Subcommittee, Marathon Pharmaceuticals refused and subsequently sold the drug to Valeant Pharmaceuticals. According to Hao, this sale shot the drug price up to $1,200 per dose on the day of sale. "This is gross misuse of our free market, and it's impacting the quality of care, access to care, and our ability to take care of patients."

http://www.healthline.com/health-news/how-an-fda-program-lets-drug-companies-raise-prices-101614#2

Your doctor hands you a prescription, explaining that she is giving you an older, inexpensive drug. At the pharmacy, you find the cost is many times the price you expected to pay. Why? The answer is that the drug has been recently reviewed for its safety and effectiveness, and there are no other brand-name or generic equivalents available. But how could a new safety review of an old drug multiply its price?

...

If a product is not approved by the FDA, the agency can require a New Drug Application from the manufacturer, which is reviewed to determine if the drug meets FDA standards. Drugs that pass this review are then the only products of their kind that meet FDA standards, giving drug manufacturers the exclusive right to sell the drugs for a period of time, just as with any new drug. Only when the patent protection ends can other companies file applications to make and sell their generic equivalents, even if the drug has already been on the market for decades.

The net result is that an inexpensive drug is studied, exclusive rights to sell the drug are given to the first manufacturer who meets the FDA standard, and the manufacturer can then decide what to charge — with no competition.

The practice is similar to "flipping" homes in the real estate business. Buyers buy up older houses in nice neighborhoods and "flip" them, making some basic fixes and then immediately selling them at a high profit margin.

https://www.pharmamedtechbi.com/publications/rpm-report/first-take/2015/4/what-does-fda-have-to-do-with-drug-pricing

But they also offer an interesting range of steps that they believe FDA can take to help:

Approve more generic drugs: Okay, even FDA owns up to this as a core activity that does help contain overall drug spending. Clinton includes a specific call for enhanced funding to support the activity – even naming the specific office responsible in FDA: “Clinton’s plan will fully fund the FDA’s Office of Generic Drugs to clear out their multi-year generic drug approval backlog, which has kept competitors off the market, and can help lower overall prescription drug prices.” Of course, OGD has just gotten significant enhanced funding from a new user fee program—and has only just begun to move through the hiring and training phase into what appears to be more efficient reviews.

Accelerate biosimilar approvals: Clinton also proposes an accelerated pathway for first-biosimilar approvals (along with calls for reduced exclusivity for innovator products): “The FDA should also give prioritized, expedited review to biosimilar applications that only have one or two competitors in the marketplace (situations where such drugs are most likely to be excessively priced).” FDA currently gives biosimilar applications a 10-month review under terms of the biosimilar user fee program – though only one has actually been approved within that timeline.

Administer a re-importation program: One of the standbys from the Democratic talking points on drug pricing is to allow importation of cheaper priced products from Canada or abroad. Clinton, not surprisingly, calls for legislation to allow importation, and would direct “FDA and other regulatory agencies would set careful standards for re-importation to ensure safety and quality.”

Revive DTC user fees: Clinton’s plan includes provisions to eliminate the tax deductibility of direct-to-consumer advertising spending – and also to revive the DTC advertising user fee program negotiated by industry and FDA in 2002 but never implemented because of objections from appropriators in Congress. “Clinton’s plan would establish a mandatory FDA pre-clearance procedure for these ads funded through user-fees paid for by pharmaceutical manufacturers in order to be sure that the ads provide clear and understandable information to consumers.”

much more ...

Btw, in addition to Big Pharm execs. whining about high R & D costs while paying themselves exorbitant salaries, anyone notice the proliferation of slick, expensive commercial advertisements for medications for diseases on TV and in the media lately? It's excessive and used to be prohibited in the US and still is in Europe I think.

to more than just those of us who already appreciate his positions. Just sayin...

Thanks for the thread, mhatrw.

He's right, the industry's greed is a public health hazard.

Bush* did a big disservice to not allow price negotiations for those of us on Medicare. But I'm willing to bet his new drug program wasn't so much for Americans as it was for profits & kickbacks.

Americans need a break. I feel for the family who cannot afford prescriptions for their children. My scripts cost me an arm and a leg each month, & that's my co-pay.

I wonder if Bernie has someone in mind who could do the job.

The nominee is not very progressive.

Meet the new boss, same as the old boss.

He is a man of his convictions. It matters not the feathers ruffled he does as he sees it being the right thing to do. I like a person who can do that very much. That kind of person is always a good leader. Ike and JFK were that kind of person, so was Carter, for that matter so was FDR and Harry Truman. I don't go back far enough to remember the others, really don't remember FDR but I've read so much about him and I was declared disabled and was getting a disability check each month long before I was old enough to retire and if not for FDR that wouldn't have ever happened. I'd be living on the street or dead today if not for him and Truman. Thats the fact of the matter anyways.