5- SUNSHINE ACT & LA LOI BERTRAND by PHARMAGEEK

L'agence nationale du médicament, sommée par la justice de produire des documents sur le Levothyrox, substitut hormonal au cœur d'un scandale sanitaire, les a caviardé au nom de la loi sur le secret des affaires. C'est une première.

The issue of conflicts of interest has become more pressing in recent years as drug prices soar and healthcare companies reach out to the academic and policy community for advice — often with generous payments attached, ethics experts say.

When Dr. Mark McClellan sat for an in-depth 30-minute question-and-answer session at an April health policy forum, the audience was filled with top researchers, advocates and Capitol Hill staffers eager to hear what insight the former head of the Food and Drug Administration would dispense.

He did not disappoint.

In response to a question about how competition might drive down the cost of new drugs made from living cells, McClellan said, “That is a great example of where more clarity from FDA about what exactly is required could potentially open up more biosimilar competition.”

McClellan is director of the Margolis Center for Health Policy at Duke University, the academic position by which he’s commonly identified. But he frequently has not disclosed another position he’s held since late 2013: He earned $285,000 last year on the board of pharmaceutical giant Johnson & Johnson, a company accused of blocking the sale of Pfizer’s Inflectra biosimilar, which competes against J&J’s blockbuster Remicade, a rheumatoid arthritis drug.

Via Dominique Godefroy

The two big groups that lobby on behalf of drug companies set a new record for their collective spending in the first year of the Trump administration.

Shelling out a combined sum of nearly $35 million to lobby the federal government in 2017, the Pharmaceutical Research and Manufacturers of America and the Biotechnology Innovation Organization upped their expenditures at a time when the sweeping tax overhaul was on the line and fears of a crackdown on drug pricing were top of mind. Remarkably, however, the record-setting spending push came in spite of the fact that neither group took a position on the biggest health policy story of the year, the long and steady Republican quest to repeal and replace the Affordable Care Act.

PhRMA came just short of breaking its own record. The group spent more than $25 million — just about $700,000 shy of its spending total in 2009, at the height of the debate over the ACA in the first year of the Obama administration. BIO spent more than $9 million, the most since at least 1999, the earliest year quarterly lobbying spending is available online for the two organizations.

The groups spent their lobbying dollars on some of the issues that generated big headlines of 2017: the new law that rewrote the tax code. Legislation concerning drug pricing. Right-to-try. Drug importation. Accelerated pathways for drug approvals. Policy issues around incentives to encourage development of drugs for rare diseases. And the confirmation of Alex Azar, President Trump’s pick to lead the Health and Human Services Department. 

 

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Via Pharma Guy

While endeavoring to protect the interests and well-being of their patients and maintain professional competence, physicians may develop secondary interests such as the competition for patients and…

Via Market iT

K pharma industry organisation the ABPI has unveiled proposed changes to its Code of Practice, aimed at reflecting changes industry practices and relations with healthcare professionals.

There are 45 proposed amendments to the Code in total in the consultation, covering a wide range of industry practices. These include the growth of conditional marketing licences, discussions with the NHS about 'service redesign', the certification of digital materials, the provision of services and genetic tests to the NHS, as well as updates to how healthcare professionals are asked to disclosure payments from pharma.

Mike Thompson, chief executive of the ABPI, said: “In the 60th anniversary year of the ABPI Code, the 70th anniversary of the ABPI and the 25th anniversary year of the PMCPA, we are proud to launch this open-to-all consultation.

The ABPI's Mike Thompson

“The views of those we work with are very important to us - including the NHS, health professionals, patient organisations, regulators and government as well as the pharmaceutical industry.

“We look forward to receiving contributions and comments on this important consultation.”

One notable amendment aims to clarify the marketing of medicines granted a conditional licence, an increasingly common occurrence, especially in cancer therapies. The proposed changes clarify that a conditionally approved treatment can be promoted, but that it must be clearly communicated that it is approved on a conditional licence.

Another amendments is looking to free-up the compliance process within pharmaceutical companies.

The current code of practice states that printed promotional material based off an already-certified digital version still requires a subsequent signatory.

However, the new amendment proposes removing this rule, to allow the printed material to be checked by an appropriately qualified person, rather than a signatory.

Speeding up the compliance process was also tried and tested following the Code’s 2016 amendment, which only required one suitably qualified person to sign off on promotional materials, abolishing the previous two-signatories rule.

Despite the close attention paid to complying with Code, some major transgressions still regularly occur. Earlier this year, Martindale Pharma, Pierre Fabre, Janssen and Pharmasure were all named in adverts following serious breaches the Code. These cases included instances of promoting an unapproved medicine and providing healthcare professionals with a hamper of chocolates.

Heather Simmonds, director of the PMCPA, said: “The ABPI Code of Practice is a living document, which is regularly updated. It reflects UK law and other requirements, such as international and European Codes to support high quality patient care. We always welcome views on its content and operation to ensure high standards and that confidence in self-regulation is maintained."

Once the consultation closes, the ABPI Board will agree on final proposals, which will be voted on by the ABPI and member companies. The code is also expected to see further changes next year to remain in line with changes from the IFPMA and EFPIA codes.

The updated code is expected to come into operation at the beginning of January 2019, with a proposed transition period until the end of April 2019.

Via Plus91

In an unusual administrative move – without passing any new laws – on December 22, 2017, the Attorney General of New Jersey finalized new rules governing physician interactions with pharmaceutical …

Via Market iT

To explore Open Payments Data

Via Market iT

Researchers and companies have to work together.

 

Few issues are more foundational to driving improvements in human health than creating productive, progressive relationships between clinical medicine and the biopharmaceutical industry. The big public health problems that humanity faces today — including Alzheimer’s disease, cancer, and metabolic and infectious disease — will not be solved by either sector working in a silo. But the interface between the two has never been more tense. Legitimate concerns over conflict of interest that have resulted in overly extreme preventative policies are a central cause. It is time for all parties to revisit those policies and replace them with rules that recognize both true conflicts and true confluences of interest. They are essential to forging the strong collaborations that are worthy of society’s trust.

Via Giuseppe Fattori

Conversations centered on health care are increasingly taking place on social media. For example, doctors, patients, advocates, the FDA and members of the pharmaceutical industry frequently interact on Twitter, discussing new drugs and devices. 

Research has shown that 60 percent of physician tweets are health-related and 14 percent mention commercial products or services. What wasn’t widely known, until now, is those physicians may have financial conflicts of interest with industry they are not disclosing.  

Vinay Prasad, M.D., M.P.H., an assistant professor of medicine (hematology and medical oncology) in the OHSU School of Medicine and member of the OHSU Knight Cancer Institute, noticed potential financial conflicts of interest, or FCOI, among physicians on Twitter and realized the issue had never been formally studied. To remedy that, Prasad and colleagues investigated the prevalence of FCOI among hematologist-oncologists active on Twitter. Their findings are published today in JAMA Internal Medicine.

Prasad and team examined 57,515 Twitter accounts, assessing 634 hematologist-oncologists for FCOI. They found 72.4 percent of those users received “general payments” from industry, i.e., payments for consulting, travel, lodging, food and beverage. Of those, 62.6 percent received more than $100 in general payments and 44.3 percent received $1,000 in general payments.

The results raise an intriguing question: How should conflict of interest be disclosed and managed in an age where information, interpretation and criticism of cancer products and practices increasingly occur on social media?

“Should there be policies to disclose conflict or policies beyond disclosures? We know social media is not going away, so how do we ensure transparency among physicians and researchers?" Prasad asks.

Via Plus91

Le montant des contrats établis entre les laboratoires et les professionnels de santé, experts sanitaires, ou associations devront être rendus publics avant le mois d’avril 2017.

Via SNJMG