- Advancing Toward the Goal of Global Approval for Generic Drugs: FDA Proposes Critical First Steps to Harmonize the Global Scientific and Technical Standards for Generic Drugs (fda.gov)
...FDA launched a Drug Competition Action Plan that focuses on three key areas designed to facilitate more generic competition, promote patient access, and improve the economics of developing generic medicines...While we’ve made substantial progress in fostering more competition by resolving obstacles that can make it difficult to win approval of generic versions of certain complex drugs, increasing the speed of generic approvals, and closing down ways that branded companies game the system to prolong drug monopolies, there’s still more work to be done...So we’re opening up some new policy fronts when it comes to our Drug Competition Action Plan. And we’re re-launching that plan for 2019 with some additional initiatives. Chief among them is a new effort that FDA has proposed to the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), a key international body comprised of other regulatory authorities and the pharmaceutical industry: The pursuit of common global development standards for generic drugs...The ultimate goal of this global harmonization of scientific and technical requirements would be the attainment of a single global generic drug development program that can support simultaneous regulatory filings across multiple markets. Harmonization of these requirements is foundational to achieving a future goal of enabling global approval for high quality generic drugs.
- Azar deals woe to DTC—and a slap to Big Pharma—with vow to force prices into drug ads (fiercepharma.com)U.S. TV drug ads to carry information on prices (reuters.com)
Pharma might have thought it could fend off the Trump administration's bid to get drug prices into consumer advertising, but it was wrong...Even a last-ditch set of concessions—announced by PhRMA Monday morning—couldn't forestall HHS Secretary Alex Azar's own proposal Monday afternoon. The pharma plan was "a small step," Azar said, before saying he'd require DTC television ads to include the list price on all $35-and-up drugs covered by Medicare or Medicaid, which is essentially every drug in the pharmaceutical universe...And Azar didn't just counter. He took direct aim at the just-announced PhRMA idea.
- EU places China’s Zhejiang Huahai under increased supervision (reuters.com)
European authorities are placing Zhejiang Huahai Pharmaceutical Co Ltd under higher supervision, the European Medicines Agency said...the latest crackdown on the Chinese firm after a probable carcinogen was found in its blood pressure drug valsartan...EU authorities will now supervise the manufacture of other active substances produced by Zhejiang Huahai more closely...European authorities said late last month they had found that Huahai did not comply with good manufacturing practices and that the company’s factory in Linhai, China, was no longer authorized to produce valsartan...European and North American regulators last month found a second toxin in Valsartan that may cause cancer in humans...low levels of a carcinogen have now also been found in irbesartan made by Aurobindo Pharma, with the supply in the EU...being suspended.
- UK clinical trials fall as Brexit clouds drug approval process (reuters.com)
The number of new clinical trials started in Britain last year was 25 percent lower than the average for 2009-16, as anxiety about Brexit’s impact on future medicines regulation made companies hesitate about running studies in the country...Drugmakers’ confidence has been dented by fears research data collected in Britain might not be acceptable to the European Medicines Agency after the UK leaves the European Union...The pharmaceuticals industry has long warned that Brexit could have a serious impact on research and access to medicines, unless London and Brussels hammer out a deal for regulatory continuity and close liaison with the EMA...If there is no deal, the UK’s Medicines and Healthcare products Regulatory Agency would have to operate as a stand-alone regulator and there is no clarity over how UK data would be treated by the EMA...
- Drug giant Pfizer offers early retirement ahead of layoffs in memo to employees (cnbc.com)
...Pfizer is offering early retirement to U.S. workers ahead of layoffs early next year, it announced internally to employees…The company...employs more than 90,000, didn't say how many people it plans to cut. But it told employees…that all business units and divisions will likely lay off nonunion workers, according to materials outlining the workforce reduction program…As we prepare for growth we are creating a simpler more efficient structure which will affect some managerial roles and responsibilities. We are offering enhancements to certain benefits to lessen this effect...Overall, its workforce will shrink by "a couple percentage points,"
- Walgreens wants to be seen as a health-care company, not just a retailer (cnbc.com)
Walgreens Boots Alliance CEO Stefano Pessina says Walgreens is a "true health-care company."... Amazon has already stolen sales of everyday items and is in the process of acquiring online pharmacy Pillpack...Walgreens wants to be seen as more than a retailer...Its competitor, CVS Health, has been touting itself as a health-care company dedicated to transforming the patient experience and lowering costs in the process. To help its case, CVS is acquiring insurer Aetna...It's not that being a retailer is a bad thing. But investors want drugstores reinvent their businesses as Amazon already steals sales of everyday items like toilet paper and will soon enter the prescription drug delivery business with its acquisition of online pharmacy, Pillpack...
- Hey, pharma: Data’s more than a ‘defense mechanism,’ ad executive says (fiercepharma.com)
...most pharma companies have begun to use data to make marketing decisions, one healthcare agency data veteran sees a recurring problem in the way that data is typically utilized...Pharma marketers too often only use data after the fact, said Kevin Troyanos...Saatchi & Saatchi Wellness. While post-campaign ROI analysis is important to find out what worked and what didn’t for the next effort, it can also lead to confirmation bias...That’s when data is used to validate the HiPPO—Highest Paid Person’s Opinion..True data-driven companies use information dynamically to inform decisions, identify what works and what doesn’t work and to make changes on the fly...Pharma typically puts a lot of research into one tactic, one channel or one creative and are almost locked in to it. What happens then is that teams are leveraging data in a defensive way, essentially using it to say that the decision they made was the right one and this is why,” he said. “Pharma needs to begin to use data as a driver, not as a defense mechanism.”...
- 5 questions on the Trump admin’s bid to mandate prices in drug ads (biopharmadive.com)
The Trump administration took one of its more combative moves on drug pricing Monday, when Health and Human Services Secretary Alex Azar introduced a proposal requiring drugmakers to disclose list prices in television advertisements...The proposal sets up what is expected to be a confrontation between the drug industry and the federal government. It also raises a slate of legal, political and regulatory questions that will be debated in the coming months. Here are five of the most pressing, and what experts are saying about them:
- Can the administration actually do this?
- Would putting prices in TV ads actually help?
- Will PhRMA sue?
- Why did the Trump administration choose to make this a signature proposal?
- Which drugmakers would hate this most?
- FDA Warns Vape Company Over Vape Liquids With Erectile Dysfunction Drugs (techtimes.com)
....the FDA released a statement announcing that it issued a warning letter to China-based vape company HelloCig Electronic Technology Co. Ltd over several violations of FDA regulations...the company produces two products containing undeclared tadalafil and/or sildenafil, the active pharmaceutical ingredients in erectile dysfunction drugs...Such drugs are approved by the FDA as pharmaceutical drugs but not approved to be included in vape liquids, and are therefore considered illegally sold. Further, the agency learned that the company is marketing the products in such a way that may mislead consumers into thinking that the adulterated vape liquids are FDA approved, placing Cialis bottles and pills alongside their product...
- In public, lawmakers scold drug distributors. Come campaign season, they accept their cash willingly (statnews.com)
In the run-up to next month’s midterm elections, the country’s three largest distributors alone have given nearly $3 million to congressional campaigns. Key lawmakers from both parties — including many of the ones who publicly shamed the companies for their role in the crisis — have accepted the contributions eagerly...analysis of the current cycle’s campaign finance disclosures, two of the three largest distributors are on pace to exceed their campaign donations from 2016 — a notable increase, since campaign spending tends to stagnate in years without a presidential election...the largest contributions have gone to lawmakers who oversee investigations into those distributors or who play key roles in determining health care and drug policy...From drug companies to insurers, lawmakers routinely accept campaign contributions from the companies across the health care industry that they are tasked with regulating...Sen. Claire McCaskill, who has not accepted campaign cash from distributors, has spoken of the pharmaceutical industry’s ability to sprinkle cash “like fairy dust” around the Capitol — and to use their curried favor to stall legislation that isn’t industry-friendly...