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South Korean authorities aren’t letting Novartis off the hook easily in an ongoing bribery controversy. After a separate agency fined the drugmaker nearly $50 million over kickback payments in April, antitrust authorities in the country have just issued a new fine and complaint against the Swiss drug giant...South Korea’s Fair Trade Commission fined Novartis 500 million won ($445,000) and filed a new complaint over payments the company offered doctors between March 2011 and August 2016, according to the Korea Times...The developments come shortly after the country’s Ministry of Health & Welfare fined Novartis 55 billion Korean won—approximately $50 million—and suspended reimbursement of Exelon and Zometa for three months, alleging the company’s employees provided approximately $2.3 million in unlawful kickbacks…

It’s taken five months, but the FDA has finally issued its first untitled letter of the year for promotional infractions. The agency's promotional watchdogs scolded Orexigen Therapeutics for alleged infractions in a TV commercial for weight loss drug Contrave...the Office of Prescription Drug Promotion says the television ad misleads viewers by touting Contrave's benefits and downplaying its risks. For instance, the letter says the spot omits important risk information—including potential neuropsychiatric reactions, such as suicidal thoughts, that are highlighted in a black-box label warning...By omitting serious risks associated with Contrave, the TV ad misleadingly suggests that Contrave is safer than has been demonstrated...Orexigen is currently addressing the OPDP guidance...

Regulatory uncertainty in the wake of Brexit could leave Britain's multi-billion-pound medical technology industry out in the cold, with separate regulatory systems threatening exports and jobs…That is the warning from the Institution of Mechanical Engineers…which…became the latest group to highlight the problem of regulatory uncertainty once Britain leaves the European Union…industries from aerospace to pharmaceuticals and chemicals fear Brexit may create a regulatory vacuum…the IME called on the British government to harmonize its post-Brexit rules with EU regulations on medical devices - a category covering everything from heart stents to walking aids - or risk losing billions of pounds in exports…Leaving the EU without the UK medical technology industry suffering considerable long-term damage, particularly for small businesses, will be a huge challenge…it is vital that the UK is able to maintain continuity with the EU CE certification processes, and enable UK manufacturers to export medical devices into the 100 billion euros European med tech market…

Despite pushback from intellectual property activists...and high-profile politicians, a U.S. Army official dismissed concerns about a pending license transfer for a Zika vaccine candidate to pharma giant Sanofi...Responding to criticism of the proposed deal, the U.S. Army’s director of medical technology transfer at the Medical Research and Materiel Command, Barry Datlof, wrote...that the deal will comply with U.S. laws and will "be in the best interest of the U.S. government and the public…Originally developed by Army scientists, the immunization went into phase 1 testing with National Institutes of Health support. Sanofi joined the effort to prepare for phase 2 trials and to create a clinical development and regulatory strategy...KEI (Knowledge Ecology International )...started protesting the proposed license soon after the U.S. government disclosed the plan...Highlighting the extensive government funding for the program—$43 million so far, with the potential for more—KEI asked for pricing safeguards and argued that the license transfer would "not be legal" because it isn’t necessary to motivate Sanofi to develop the vaccine...Datlof said it’s not feasible for the Army to "define, implement and enforce 'affordable prices' or to set price controls for a potential vaccine that will require great investment and face high risk of failure."...the Army still plans to issue the license...

U.S. taxpayers may have overpaid for Mylan NV’s EpiPen shot by as much as $1.27 billion over the last decade, according to a U.S. government report...by classifying EpiPen as a generic drug rather than a brand-name product, shortchanged the Medicaid program...Under Medicaid, makers of brand-name drugs must provide deep discounts on their products. In October, Mylan said it reached a settlement with the U.S. to pay $465 million for misclassifying the drug as a generic product, which doesn’t require the same discounts...(Senator Charles Grassley)...has been critical of the...settlement, calling it too small...As part of bringing down drug costs, we have to make sure companies that take part in federal health care programs aren’t gaming the system...It’s Congress’s job...to ensure that taxpayers...don’t overpay for EpiPens or any other drugs in public health-care programs...Grassley has pushed for Mylan and the Centers for Medicare and Medicaid Services to explain why EpiPen was misclassified...

I (Adam Fein) had the privilege of meeting with Secretary of Health and Human Services Tom Price. I was invited to meet with Secretary Price for one of his listening sessions with industry experts and stakeholders. I appreciated the opportunity to share my perspectives...In our meeting, I highlighted four ways that the 340B Drug Pricing Program is raising drug costs. I then offered eight specific recommendations for improving the program by addressing the widespread channel distortions the program has caused.

HOW 340B RAISES DRUG COSTS

1. Encouraging a shift in site of care from lower-cost physician offices to higher-cost hospital outpatient settings.
2. Reducing manufacturers’ rebates to Medicare Part D and commercial payers.
3. Raising out-of-pocket costs for uninsured patients.
4. Reducing the generic dispensing rate and slowing the adoption of biosimilars.

HOW TO ADDRESS CHANNEL DISTORTIONS FROM THE 340B DRUG PRICING PROGRAM

1. Require that covered entities share financial savings from the 340B program with uninsured and vulnerable patients.
2. Revise hospital eligibility for the 340B program to create a clearer patient definition.
3. Remove incentives for extraordinary hospital profits and site-of-care consolidations.
4. Require HRSA and Apexus (the Prime Vendor) to report the size and scope of the 340B program.
5. Mandate that contract pharmacies for 340B hospitals charge no more than the discounted 340B price to uninsured, underinsured, and vulnerable patients.
6. Require contract pharmacies to identify 340B prescriptions at the time of adjudication (payer prescription approval).
7. Require the disclosure of and transparency into the fees and profits generated by 340B contract pharmacies.
8. Limit the number and geographic scope of contract pharmacy arrangements.

China’s FDA proposed changes to its foreign drug registration regulation in mid-March, aiming at speeding up approvals. The changes have provoked anticipation for growth among Western drugmakers, particularly around two provisions having to do with drug trials…

• The CFDA would no longer require that a drug be tested through phase 1 elsewhere before being tested in humans in China, and
• ...foreign drugmakers can use data from international multicenter trials that have been conducted in China to directly file for marketing approval.

...the change would attract greater investment from drugmakers and dramatically reduce the time to introduce blockbuster treatments...the new regulation "allows the imported innovative drug to move forward more naturally in China and not be required to be tied to international[-only] processes…I think [the Chinese government] has removed some significant obstacles and at the same time wishes to retain flexibility...what is clear is China’s goal to take the lead in pharmaceutical innovation, to become a launch pad of new meds...it’s about a national pride that doesn’t want to forever be left out in a global innovation discourse..."There is less the need to protect domestic industry than to play a leading role,"…Western companies will remain an "ever-present competitive force," and gradually opening up that competition will force domestic firms to up their game, to stand on their own feet and not rely on subsidies, and gradually eliminate those who cannot keep up…

The FDA needs to clarify its standards for showing a biosimilar drug is interchangeable with the original biologic and how the biosimilar should be named and labeled, commenters said in response to an agency draft guidance...The Food and Drug Administration draft...described how an applicant can establish that a biosimilar, a highly similar, less expensive version of an FDA-approved biologic drug, can be substituted for the biologic on which it is based without a physician’s approval…If you’re a biosimilar applicant, you’re happy the FDA has provided the guidance, but you think it’s asking for too much information...If you’re the owner of the patent for the original biologic, you strongly support the need for the switching studies the FDA requires in order to show that switching from the original biologic to the biosimilar is safe. If you’re an organization that represents patients, you want assurances the interchangeable biosimilar is safe and effective for each condition for which the original biologic is approved...

Buried deep in its first quarter earnings filing with the Securities and Exchange Commission, Eli Lilly & Co. disclosed it is being investigated for insulin pricing practices by the attorneys general of New Mexico and Washington. The Washington AG is looking at Lilly's relationship with pharmacy benefit managers...Insulin competitor Novo Nordisk has also said it is under investigation by the two AGs for pricing and trade practices for its insulin products, going back as far as 2005...Things are getting complicated at the moment for the big three in insulin. As well as the investigations by the attorneys general, last month, Sanofi, Novo Nordisk and Lilly, along with the pharmacy benefit managers CVS, Express Scripts and UnitedHealth's OptumRx, were slapped with a complaint and demand for a jury trial from the Type 1 Diabetes Defense Foundation.

With 18 branded drugs on the line, patent losses this year could jeopardize $26.5 billion in annual sales from Big Pharma, projected to be the biggest fall-off until at least 2025…Which companies are at risk? Roche, GlaxoSmithKline, Eli Lilly, Pfizer and AstraZeneca to name a few...This year's potential patent expiry damage is much more daunting than 2015 and 2016, when only four and nine meds from companies...lost exclusivity, respectively...Anticipated expirations for 2017 include Roche’s Rituxan, GSK’s Advair, Eli Lilly’s Humalog and Cialis, AstraZeneca’s Byetta, Pfizer’s Viagra and Merck’s Vytorin...the 2017 patent losses and associated sales declines will "continue to pressure growth" in the industry...about 45% of the sales at risk looking forward are for biologics, which will face biosimilar competition rather than generics..."erosion rates will be slower," but still "unpredictable.