- ‘One whiff and you’re stiff’: The Irish village where smoke from the local Viagra factory puts a spring in their step welcomes news the little blue pill will now be available over the counter (dailymail.co.uk)
Locals in a tiny Irish village where Viagra has been manufactured for 20 years are laughing off potentially stiff competition from Britain...Men in need of the drug will soon be able to purchase the little blue over the counter, following a public consultation by the UK Medicines and Healthcare products Regulatory Agency...But villagers from Ringaskiddy, Cork - where Pfizer manufacture a key ingredient used in Viagra - have met the news with amusement...Barmaid Debbie O'Grady told The Sunday Times: 'One whiff and you're stiff. We've been getting the love fumes for years now for free', she told The Daily Telegraph, referring to smoke emanating from one of the factory's chimneys...Ms O'Grady's mother, Sadie, even said that living in Ringaskiddy is a blessing for some men who suffered 'with problems in that department', adding that there is 'something in the air'.
- Stakeholders Comment on FDA Draft Guidance for Evaluating Biosimilarity (biopharminternational.com)
Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars...On Dec. 4, 2017, a final round of comments from industry stakeholders who raised questions over FDA’s draft guidance, “Statistical Approaches to Evaluate Analytical Similarity,” about how to conduct analytical evaluation of similarity in biosimilars, was published...Several biopharma majors were among the commenters, including Amgen, Boehringer Ingelheim, Genentech, a Roche company, Novartis, Pfizer, Sanofi, and Shire. Other industry stakeholders include the Association for Accessible Medicines, the Biosimilars Forum, and the Biotechnology Innovation Organization...FDA introduced the draft guidance in September 2017, which specifically describes the type of information that sponsors of proposed biosimilar products should obtain regarding the structural/physicochemical and functional attributes of the reference product. In addition, the guidance describes how that information can be used in the development of an analytical similarity assessment plan for the proposed biosimilar, as well as recommends the statistical approaches for evaluating analytical similarity.
- Massachusetts grabs spotlight by proposing new twist on Medicaid drug coverage (healthcarefinancenews.com)
Massachusetts' state Medicaid program hopes to road-test an idea both radical and market-driven. It wants the power to negotiate discounts for the drugs it purchases and to exclude drugs with limited treatment value..."This is a serious demonstration proposal,"..."They're not simply using [this idea] as an excuse to cut Medicaid. They're trying to take a step toward efficiency."...If the Department of Health and Human Services approves the...plan, others will likely take similar action...Currently, state Medicaid programs are required to cover almost all drugs that have received Food and Drug Administration approval, including multiple drugs from different manufacturers used for the same purpose and in the same category. In exchange, manufacturers must discount those drugs -- typically based on a set percentage of the list price...The idea is Medicaid's vulnerable beneficiaries get medications they need and the state doesn't go broke paying for them...Massachusetts wants to go a different route, requesting a federal exemption known as a Section 1115 waiver, which is meant to let states test ways of improving Medicaid. It wants to pick which drugs it covers based on most beneficiaries' medical needs and which medicines demonstrate the highest rates of cost effectiveness...It says it will be able to negotiate better prices as a result, saving public dollars while maintaining patients' access to needed therapies...
- AHIP thanks CMS for adding flexibility in 2019 Medicare Advantage and Part D rule (healthcarefinancenews.com)
New proposed rule offers insurers more plan flexibility and eases regulations...The proposed rule released last week by the Centers for Medicare and Medicaid Services would strengthen and improve the Medicare Advantage and Part D programs...CMS's proposed 2019 Medicare Advantage and Part D rule offers insurers greater flexibility in reporting and makes changes to how star ratings are calculated...Star ratings determine bonuses for insurers. Another plus for plans that have an overall 5-star rating is the ability to offer a year-round open enrollment period for Medicare Advantage...The rule has an open enrollment period for MA plans of Jan. 1 through March 31, 2019. It allows enrolled individuals to make a one-time election to go to another plan or to original Medicare...The proposed rule would get rid of artificial limits on the variety of plans an insurer can offer in a certain region, ease the medical loss ratio, allow for more tailored benefits and would revise regulations for maximum out-of-pocket limits, among other changes.
- Will Pharma Meet the Drug Tracking Deadline? (biopharminternational.com)
Manufacturers and trading partners struggle to meet drug tracking requirements...As FDA and industry near the halfway mark in the 10-year process for establishing a national electronic drug tracking system by 2023, there’s considerable concern among pharma companies, wholesaler/distributors, and pharmacists about meeting the deadline. The process for establishing the rules and infrastructure for the track-and-trace system envisioned in the Drug Supply Chain Security Act, part of the Drug Quality and Security Act of 2013, is proving to be complex and challenging for all parties...FDA recently delayed requiring drug manufacturers to imprint unique product identifiers on individual packages by November of 2017, saying it would not enforce that policy until Nov. 27, 2018. While major pharma companies are meeting the earlier time-frame for serializing and identifying drug packages, many generic-drug makers and contract manufacturers reported confusion over who is responsible for devising the identifiers and for confirming compliance with requirements. And while manufacturers applauded gaining an additional year to fully identify individual drug packages, pharmacists and other supply chain partners raised concerns that the delay would make it even more difficult for them to comply with reporting requirements for 2018 and 2019...
- CVS to Buy Aetna for $69 Billion in a Deal That May Reshape the Health Industry (nytimes.com)CVS-Aetna deal will change the way many big employers buy employee health-care benefits (cnbc.com)The CVS/Aetna Deal in 5 Quotes Now that an official proposal has been announced, how are industry leaders responding? (drugtopics.modernmedicine.com)
CVS Health said on Sunday that it had agreed to buy Aetna for about $69 billion in a deal that would combine the drugstore giant with one of the biggest health insurers in the United States and has the potential to reshape the nation’s health care industry...The transaction, one of the largest of the year, reflects the increasingly blurred lines between the traditionally separate spheres of a rapidly changing industry. It represents an effort to make both companies more appealing to consumers as health care that was once delivered in a doctor’s office more often reaches consumers over the phone, at a retail clinic or via an app...A combined CVS-Aetna could position itself as a formidable figure in this changing landscape. Together, the companies touch most of the basic health services that people regularly use, providing an opportunity to benefit consumers. CVS operates a chain of pharmacies and retail clinics that could be used by Aetna to provide care directly to patients, while the merged company could be better able to offer employers one-stop shopping for health insurance for their workers.
- FDA issues guidance that could make it easier for EpiPen rivals to come to market (cnbc.com)
When the controversy over the price of the EpiPen exploded late last summer, many consumers asked why there was no substitutable generic version available...The answer was complex: while the key ingredient in the anaphylaxis treatment, epinephrine, has been available for decades and is no longer covered by a patent, the delivery device proved hard for generic competitors to copy to a degree that would satisfy regulators...the Food and Drug Administration announced guidance seeking to change that, potentially streamlining a path to market for generic copies of complex medicines like the EpiPen and others...The FDA guidance says that generic copies with some design differences may be approved as substitutable products, as long as those differences don't affect patients' ability to use the product the way it's intended...Dr. Scott Gottlieb, said.."Under this guidance, so long as the generic applicant is able to demonstrate with data, where appropriate, that differences in design of the generic product do not affect the clinical effect or safety profile when the generic is substituted for the branded product, the generic product can be approved as a competitor to the branded drug where all other requirements for generic approval are met,"...
- EMA Updates Brexit Guidance (biopharminternational.com)
The agency and the European Commission published updated guidance to answer questions about Brexit...On Dec. 1, 2017, the European Medicines Agency and the European Commission published updated guidance for pharmaceutical companies regarding the United Kingdom’s withdrawal from the European Union. The new guidance answers additional questions about marketing applications and authorizations...New in this update is more information on batch release sites located in the UK, which must be located in the EU; the effect on herbal medicinal products; and applications for orphan drug designation. The guidance also discusses the local representatives in the UK mentioned in product information, global marketing, and the sunset clause.
- OTC Viagra: Pfizer snags nod for nonprescription sales of the little blue pill for men in the U.K. (fiercepharma.com)
Pfizer has won a first approval for OTC Viagra. Viagra Connect, the Pfizer OTC name for its blockbuster erectile dysfunction drug, has been approved for sale in the U.K...The Medicine and Healthcare products Regulatory Agency announced...that it will reclassify the 50 mg dose from prescription only to a pharmacy medicine in the U.K. Viagra Connect is expected to be available for sale in the spring of 2018. Anyone seeking to buy the drug will be required to have a discussion with a pharmacist, who will determine whether the drug is appropriate for their use...It will continue to sell branded versions of other doses of the drug in the U.K...In regard to its U.S. OTC ambitions, Pfizer said, in a statement to FiercePharma, “While we do not have information to share on specific Rx to OTC switch programs in the United States, generally we consider prescription drugs—both within the Pfizer portfolio and outside it—for potential switch to non-prescription status. Our objective is to provide consumers with significantly greater access to medicines with well-established efficacy and safety profiles without a prescription.”
- Heated And Deep-Pocketed Battle Erupts Over 340B Drug Discount Program (khn.org)
A 25-year-old federal drug discount program has grown so big and controversial that it faces a fight for survival as federal officials and lawmakers furiously debate the program’s reach...The program, known as 340B, requires pharmaceutical companies to give steep discounts to hospitals and clinics that serve high volumes of low-income patients...The Centers for Medicare & Medicaid Services...cut Medicare payments for hospitals enrolled in the program by 28 percent...About 40 percent of the hospitals in the U.S. now buy drugs through the program...the hospital lobbying group 340B Health, said that for some small, rural hospitals the funding cut “could actually be the difference between staying open and closing.”...those supporting the cut, including drugmakers, argue that the program has grown beyond its original intent because hospitals have pocketed the discounts to pad profits — not to help indigent patients...Stephen Ubl, president of drug industry group PhRMA, said the program “needs fundamental reform” and that the latest rule change is merely a good first step. His group, which has deep pockets and an advertising campaign geared at pinpointing the program’s flaws, has a list of changes that Congress and the Trump administration could tackle. Those include limiting which hospitals should be eligible for 340B price breaks and making sure needy patients benefit when hospitals buy discounted drugs.