Scott Gottlieb agarra puerta... "giratoria" a Pfizer

Former Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD has joined the board of directors of Pfizer, Inc.—the world’s largest pharmaceutical company and second largest manufacturer of vaccines. Pfizer, which posted total revenues of $53.7 billion in 2018, announced Dr. Gottlieb’s election to the board on June 27, 2019.

Dr. Gottlieb, who led the FDA from May 11, 2017 to Apr. 5, 2019, has also been appointed to the Regulatory and Compliance Committee and the Science and Technology Committee of Pfizer’s board. 

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Scott Gottlieb dice adios, firma y promete...

In response to the Pfizer announcement, U.S. Senator Elizabeth Warren (D-MA) wrote a letter to Dr. Gottlieb on July 1. 
She said, 

“this kind of revolving door influence-peddling smacks of corruption, and makes the American people rightfully cynical and distrustful… ” 

and suggested that Dr. Gottlieb should 

“rectify” his “mistake and immediately resign” from his position on the board. 

She added: 
“Doing so would send a strong and necessary message to the American people about the importance of government ethics and the integrity of current and former federal officials.” 

Warren noted that, according to Pfizer, the company’s board members were paid “$142,500 in cash retainers in 2018, plus received $192,500 worth of Pfizer stock.“

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The Revolving Door Didn’t Start at Pfizer

  Prior to his appointment as FDA commissioner, Dr. Gottlieb served on the board of directors of pharmaceutical companies Tolero Pharmaceuticals, Inc. and Daiichi Sankyo Co. He also served on the investment board of GlaxoSmithKline plc (GSK), currently the fourth largest vaccine maker in the world.

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Scott Gottlieb dice adios, firma y promete...

Scott Gottlieb signed off from his remarkable but brief tenure as FDA commissioner yesterday, completing his final week with a series of announcements across priority areas.

Gottlieb has served less than two years in the post, but has proven to be one of the most energetic, reforming and outspoken FDA commissioners in recent memory, earning praise from politicians, regulators and the pharma industry for his leadership.

This was based on Gottlieb’s bold approach to addressing unnecessary barriers to innovative medicines approvals, while at the same time tackling bottlenecks in generic drug approvals and pricing and competition issues, including ‘naming and shaming’ companies which obstruct generic competition.

He now hands over to interim FDA commissioner Ned Sharpless, formerly head of the National Cancer Institute (NCI), but ended his final days in the post with a redoubled focus on key issues. These included 

• .promoting AI-based medical devices, 
• .new regulatory pathways for cannabis-based medicines, 
• .combating illegal online sales of opioids, 
• .renewing efforts to cut smoking and tobacco use, and 
• .bringing competition to US insulin markets. (...)

These remarks add to commentary Gottlieb made on the wider question of competition and drug prices last week at a Alliance for a Stronger FDA meeting last week.

Talking in a ‘fireside chat’ with former FDA commissioner Mark McClellan, Gottlieb commented on the ongoing debate about how the US should control its drug prices.

He said he believed area there should be price competition in Medicare Part B, which covers medicines dispensed in the doctor’s office.

"The government is largely a price taker [in Part B] and those drugs aren't competitively bid; I think we need to think about that," he said.

This would once have been a radical view for anyone in the US, let alone for a politically-appointed FDA commissioner, but the drug pricing debate has moved on during the Trump presidency and in Gottlieb’s tenure.

Asked to comment further, Gottlieb demurred on this occasion, but concluded: “Well, I’ll have a lot more to say on that in about seven days”.

Losing Gottlieb’s dynamism, FDA-watchers are also concerned that it could take a long time for a permanent successor to be appointed, as the Trump administration has a poor record in filling many senior posts across government. However, in Twitter exchanges with his immediate predecessor Robert Califf and new commissioner Sharpless, the emphasis was on continuity.

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FDA: Se va Scott Gottlieb y deja mensaje ...

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Food and Drug Administration Commissioner Scott Gottlieb resigned Tuesday, in a surprising departure from the Trump administration.

Gottlieb, 46, was sworn into leadership of the $5.1 billion agency in May 2017 and had generally been seen as a quiet and effective leader. He had previously served at FDA during the second Bush administration as a deputy commissioner, with a background as a physician and public health policy expert. News of his resignation was first reported by the Washington Post, with his departure timed for the next month.

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FDA: Trump apostó por O’Neill pero se decidió por Gottlieb

In a letter to FDA staff, which the agency shared on Twitter, Gottlieb explained that he wanted to spend more time with his family. “There’s perhaps nothing that could pull me away from this role other than the challenge of being apart from my family for these past two years and missing my wife and three young children,” he wrote. He also thanked them for “their sacrifice over the past two years.”

In his resignation letter, Gottlieb wrote: “I’m fortunate for the opportunity that the President of the United States afforded me to lead this outstanding team, at this time, in this period of wonderful scientific advances.”

He then reflected on what he described as his agency’s signature policies, from seeking to reduce morbidity associated with tobacco use to confronting e-cigarette use by teens, to fighting opioid addiction rates, to improving food safety and tracking foodborne illness outbreaks.

“We cracked down on bogus stem cell therapies, on sham homeopathy, on unsafe medical device products, on tobacco sales to minors, on unsafe dietary supplements, and on kratom,” Gottlieb wrote.

He also noted that the FDA approved a “record number” of generic medicines, prescription drugs, and medical devices in 2017, and then again in 2018.(Más)

FDA / Trump ...en genéricos.

“Our work is not done. 

We’ll continue taking additional steps 

to help ensure patients have access 

to the drugs they need 

by making generic drug approval 

more efficient and predictable. 

We are doing this by continuing 

to streamline the generic drug review process 

to get more competitors on the market. 

We have found 
that having three or more generic competitors

 brings prices down more sharply

 than with only one or two generic competitors.”

Scott Gottlieb FDA Commissioner

 

PWC Study on Faster Approval of Generic Drugs 



The FDA has substantial new authority, resources and resolve to make it easier for generics to come to market, viewing competition as a key way to bring down drug prices. These efforts likely will succeed in bringing new generics to the market more quickly and predictably, but significant competitive hurdles may limit their impact on drug pricing or competition without complementary efforts to address the biologics market. Already, the FDA is setting records for the number and speed of its generic drug approvals. The FDA fully approved 763 generic drugs in fiscal year 2017, according to an analysis by PwC’s Health Research Institute (HRI). That is 86.5 percent more than in fiscal year 2014, the first full year the Generic Drug User Fee Act was in effect, when it approved 409 (see Figure 1). And the agency is approving these drugs faster than it was even a few years ago. 

For some generics, approvals are coming in as few as eight months instead of the previous standard of 15 months in fiscal year 2016. (Más)

 

FDA "nos vacuna" ante terrorismo

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U.S. regulators Friday approved the first treatment for smallpox — a deadly disease that was wiped out four decades ago — in case the virus is used in a terror attack.

Smallpox, which is highly contagious, was eradicated worldwide by 1980 after a huge vaccination campaign.

But people born since then haven’t been vaccinated, and small samples of the smallpox virus were saved for research purposes, leaving the possibility it could be used as a biological weapon.

Maker SIGA Technologies of New York has already delivered 2 million treatments that will be stockpiled by the government, which partially paid for the development of the drug, called TPOXX.

To test the drug’s effectiveness, monkeys and rabbits were infected with a similar virus and then given the drug. More than 90 percent survived, the company said. Its safety was tested in several hundred healthy volunteers, who were not infected with smallpox.

Smallpox killed about 300 million people worldwide in the 20th century before its eradication. Symptoms include fever, fatigue and pus-filled sores. Until now, doctors could only provide supportive care such as IV fluids and fever remedies and isolate the patients. Vaccination can be used to prevent infection but it must be done within five days of exposure to the virus, well before symptoms appear.

“This new treatment affords us an additional option should smallpox ever be used as a bioweapon,” Dr. Scott Gottlieb, head of the Food and Drug Administration, said in a statement.

The drug is a capsule, taken twice daily for 14 days.

SIGA develops vaccines and medicines for biological, chemical, radiological and nuclear attacks. Chief Executive Phil Gomez said the company is developing an IV version and is exploring selling the drug to other countries and developing it to treat other infectious diseases, including monkeypox, which African monkeys can transmit to humans. Monkeypox can then spread among people, and has a mortality rate of about 15 percent. (Ver)

USA: FDA aprueba EPIDIOLEX primer cannabinoide

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The Food and Drug Administration on Monday approved the country’s first drug derived from marijuana, a medication that treats two rare and devastating forms of epilepsy.

The drug, GW Pharmaceuticals’ Epidiolex, is made of cannabidiol, or CBD, a component of marijuana that does not give users a high. It is given as an oil, and in clinical trials, it was shown to reduce the number of seizures by about 40 percent in patients with Dravet or Lennox-Gastaut syndromes. 

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GW Pharmaceuticals dobla su valor gracias al cannabis (Epidiolex)

“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies,” FDA Commissioner Scott Gottlieb said in a statement. “And, the FDA is committed to this kind of careful scientific research and drug development.”

The FDA’s decision was expected. FDA officials had indicated they supported approving Epidiolex, and an advisory panel had unanimously recommended it get the green light. There was some concern about the drug’s effects on the liver, but experts have said this risk could be addressed by doctors as they monitor their patients during treatment. (Ver)

FORTUNE: World´s Greatest Leaders

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5. Kenneth Frazier CEO, Merck

It’s easy to forget that last August, after President Trump’s tepid response to a white nationalist rally that turned violent, outcry from the business community was not immediate. Frazier took a risk by becoming the first of Trump’s advisers to speak out and step down, enabling others to follow suit.
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Frazier Vs Trump: Frazier's call earns him praise, rare for a pharma CEO / Y Gorsky también renuncia.

USA: Most Investors Respect The Merck CEO’s Decision To Resign From Trump’s Council

Kenneth C. Frazier (Ceo Merck) renuncia a la Presidencia de American Manufacturing Council

His success at Merck only bolsters his credibility: Since he took over in 2011, the pharma giant has made strides in treating several cancers, while its stock beat the S&P 500.

6. Scott Gottlieb FDA commissioner



It’s hard to imagine a federal agency that touches more of our lives—and in more personal ways—than the Food and Drug Administration. It reaches in through our medicine cabinets, regulating everything from our morning pills to makeup—and through our kitchen cupboards, ensuring the safety of most of what we ingest each day, even bottled water. Its purview extends from pet food to microwave ovens to vaccines, pacemakers, and bedpans. And in the year since he has been FDA commissioner, Scott Gottlieb has appeared to have had a direct hand in all of it.

"In Gottlieb and HHS Director Alex Azar, 

a former Eli Lilly executive, 

the pharma industry has allies in Trump's administration. 

It remains to be seen just how the administration 

will try to fulfill its promise on drug prices, 

but early reports indicate 

it'll be through tactics proposed by Gottlieb, 

plus value-based pricing 

and other largely industry-friendly approaches."

Eric Sagonowsky 
 FiercePharma May 15, 2018

Ver:

FDA: Trump apostó por O’Neill pero se decidió por Gottlieb

Seven pharma trends for 2018

Gottlieb, a physician and former VC who served as a deputy commissioner in the administration of President George W. Bush, has earned broad kudos from a constituency that is often beset by bitter argument. He has pushed for creative ways to slow the skyrocketing rise of medicine prices (in part by making it easier for generics to compete), helped speed the development of digital health technologies through clearer regulatory guidance, embraced more efficient clinical trial designs, and aggressively tried to reduce cigarette smoking and contain America’s raging opioid epidemic through sharp policy moves. 
An avid (perhaps even obsessive) tweeter, Gottlieb @ScottGottliebMD has gotten credit for being transparent about FDA steps—and, more important, for using his bully pulpit without being a bully.  

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Seven pharma trends for 2018

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1. _The value of medicine or how to aggressively price a medicine                                                                                      It is inevitable that pricing debates will be taken up again in earnest next year, not least because one of the major stories to break towards the end of 2017 was the announcement that Spark Therapeutics historic approval for the first gene therapy for an inherited disorder was given by the FDA. Why is that significant in the pricing debate? Only because it might break a few pencil leads at HTA offices if the rumoured $1 million price tag per patient is followed through on. 
2. _A record-breaking year for US drug approvals?                 Some of this success may be down to FDA Commissioner Scott Gottlieb’s leadership, who joined the organisation in May. Under his direction, expect even more total approvals by the end of next year as the FDA looks to integrate major changes to the way it regulates medicines and medical devices – especially in the cancer space, where Gottlieb has recently outlined plans to allow for already-approved treatments to be authorised in a second indication based on supplemental applications. 
3. _Technology continues to amaze 
4. _Mergers and acquisitions set to return with a bang? What awaits for 2018?                                                                          It is thought that President Trump managing to push his tax reform through the US Senate could see previously cautious US pharma companies bring their money back to North American shores for an almighty acquisition splurge. In particular, Pfizer has played it cool for the past year, waiting for the right moment to splash the cash after its previously failed attempt at a mega-tax inversion. It is unlikely to be the only company to make significant moves, as an M&A carousel loosens everyone’s pockets. 
5. _Personalised medicine to show even more potential 
6. _The North American opioid crisis 
7. _Nothing is certain except uncertainty (just ask those who live in the UK) 

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FDA "da fé" y advierte...: Marihuana no cura cáncer.

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Marijuana doesn’t cure cancer. It has not been shown to somehow explode tumor cells or promote the growth of new brain cells, the Food and Drug Administration said Wednesday.

The FDA warned four companies to stop making these unproven claims and to stop selling cannabis-based hemp and marijuana products that claim to treat cancer or any other medical condition.

“Substances that contain components of marijuana will be treated like any other products that make unproven claims to shrink cancer tumors,” FDA Commissioner Dr. Scott Gottlieb said in a statement.

The FDA says it is not trying to shut down the sales -- just to stop sellers from making unproven medical claims.

“We don’t let companies market products that deliberately prey on sick people with baseless claims that their substance can shrink or cure cancer and we’re not going to look the other way on enforcing these principles when it comes to marijuana-containing products.”

Medical marijuana is legal in 29 states, as well as in Guam and Puerto Rico. Studies have shown that it can have some benefits in reducing anxiety, counteracting some types of nausea, and that it may relieve some symptoms of glaucoma and multiple sclerosis. (Más)

Ver también:
FDA Regulation of Marijuana: Past Actions, Future Plans Douglas C. Throckmorton, M.D.Food and Drug Administration (FDA)

FDA: Trump apostó por O’Neill pero se decidió por Gottlieb

President Donald Trump has named Scott Gottlieb as his choice for the new commissioner of the FDA, a choice that will be welcomed by pharma but is already making waves among those who believe his ties to the industry are a concern.

A medical doctor, former FDA deputy commissioner and health policy expert, Gottlieb has the credentials to take over from previous commissioner Robert Califf, who stepped down from the post on January 20 after Trump's inauguration. 

He is certainly more of a mainstream choice than the other candidates mentioned in dispatches - tech capitalist Jim O'Neill, computational biology expert and tech investor Balaji Srinivasan and Joseph Gulfo, a healthcare technologist and outspoken FDA critic.

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FDA: Trump apuesta por Jim O’Neill (Pro-Cannabis)

Gottlieb has close links with the pharma industry however, sitting on the board of several small biopharma companies as well as being an advisor to GlaxoSmithKline (GSK), and is a partner at venture capital fund New Enterprise Associates and managing director of investment banking firm TR Winston & Co. Those ties to the commercial side of the drug industry have left some in the healthcare sector wary, particularly as he is an advocate of cutting regulations at the FDA – something Trump himself has said is a key reform goal – to make it easier to get new drugs and medical devices to market. 

Some lawmakers have been making their reservations clear, with Senator Patty Murray (D-WA) tweeting: "There are concerns w/ Dr. Gottlieb's record & about how his views would impact our ability to maintain the "gold standard" of #FDA approval." 

Meanwhile, a perusal of the comments below this Medscape article on the nomination suggests that the nomination is polarising doctors, much like Trump's choice of Tom Price to run the Department of Health and Human Services (DHHS), which was announced in December. 

Industry body the Pharmaceutical Research and Manufacturers of America (PhRMA) welcomed the nomination, saying that Gottlieb's "extensive experience as a physician and breadth of healthcare knowledge will help ensure the FDA continues to play a vital role in protecting public health and innovation in the agency’s review and approval of new medicines for patients in need". 

Consumer advocacy group Public Citizen is less enamoured. 

The group said in a statement that Gottlieb is "entangled in an unprecedented web of big pharma ties. He has spent most of his career dedicated to promoting the financial interests of the pharmaceutical industry". 

"When Gottlieb served as FDA deputy commissioner, he was recused from many key meetings and decisions due to his close relationship with industry," it asserts. The President's choice still has to win the backing of the Senate, and the confirmation process will kick off with a hearing in front of the Senate Health, Education, Labor and Pensions (HELP) committee, currently controlled by Republicans. (Ver)