Pharma's worst nightmare? Leaked Democrat pricing plan calls for negotiations, price index, fines and more

FiercePharma | September 10, 2019

Pharma watchers have been awaiting House Speaker Nancy Pelosi’s drug pricing plan, and on Monday the industry got a peek at what Democrats are discussing to lower drug prices. The upshot? If the House leadership gets its way, it would devastate pharma's pricing power. The leaked document is outdated and the proposals could change, a senior aide told The Hill. The industry would put up fierce opposition, and Republicans could well balk, too. But the bullet points offer a glimpse into the talks behind closed doors that could end up out in the open—and on the House floor. In the draft drug pricing plan, published by Bloomberg Business, Democrats suggest authorizing the HHS secretary to negotiate prices for the top 250 drugs that don’t have at least two generic or biosimilar rivals. That would include the industry's biggest sellers, such as AbbVie's behemoth Humira and Merck & Co.'s powerhouse Keytruda. The plan also calls for an international price index to peg pharma’s U.S. prices to the much lower stickers overseas. It would also levy steep fines to keep drugmakers in line and place limits on price hikes, among other things.

Spotlight

The introduction of counterfeit pharmaceutical products into the legitimate supply chain has become a global threat over the past years.

Spotlight

The introduction of counterfeit pharmaceutical products into the legitimate supply chain has become a global threat over the past years.

Related News

BUSINESS INSIGHTS

Element Further Expands Its Life Sciences Testing Business With Additional Pharmaceutical and Biotech Testing Capabilities in North America and Europe

Element Materials Technology | January 15, 2022

Element Materials Technology (Element) completed its sixth life sciences-focused acquisition of 2021, with the formal completion of the acquisition of JMI Laboratories. Element has now built out its expertise and capability for pharmaceutical and biopharmaceutical customers, expanding to a team of more than 1,000 experts in 23 facilities across North America and Europe. This significant step change in pharmaceutical and medical testing capabilities from Element forms part of its broader strategic shift to increase its global presence in Life Sciences and Connected Technologies. “Our expansion into life sciences and connected technologies over the last two years has seen us gain a leadership position in these strategically important end-markets. As we celebrate 10 years of being a standalone Element business, we see more and more opportunities to work closely with our customers throughout their product and testing lifecycles.” Jo Wetz, Element CEO Cherie Gudz, Vice President, Life Sciences Americas, said: “In a world still dealing with a pandemic, the life sciences sector has never been more vital. The six acquisitions this past year alone cements Element’s commitment to continue to build a scale business in this vital sector, which now forms our largest global end-market. We are thrilled to have JMI’s team and expertise join the Element family”. Based in North Liberty, Iowa, JMI is a market leader in antimicrobial resistance monitoring studies utilized for US-FDA regulatory and new drug application submissions, through their proprietary SENTRY Antimicrobial Surveillance Program. It offers microbiology and molecular testing services to assist in the development of new antimicrobials and clinical trial support. The Company is CLIA accredited and able to test under GLP conditions. The business is notable for its team of highly scientific and well-published industry recognized experts in the field, including 10 MD/PhDs with extensive knowledge of microbiology and antimicrobials, and can consult on a broad range of scientific topics covering epidemiology, mechanisms of resistance in bacterial and fungal organisms, microbiology diagnostics and susceptibility testing methods.

Read More

BUSINESS INSIGHTS

NanoPass and M2N enter strategic development & foundry agreement

NanoPass; M2N | December 23, 2021

NanoPass Technologies and Micro2Nano have reached an agreement to enter a strategic development and production relationship for the design and production of NanoPass's proprietary MEMS based microneedles. The aim of the collaboration is to strengthen the relationship between NanoPass and M2N and provide a basis for the continued growth of the two comaim of the collaboration is to strengthen the relationship between NanoPass and M2N panies while basing the new agreement on years of development and production collaboration. M2N has been an integral and inseparable part of Nanopass's development and manufacturing capabilities since 2007 and has been providing Nanopass with high quality foundry services, ingenuity and quick turn-around on development projects. NanoPass's proprietary technology platform is based on hollow, pyramid-shaped, microneedles. It is produced from silicon crystal using MEMS technology. The technology can be used for intradermal delivery of a wide range of injectables including vaccines and therapeutics, aesthetics, cosmetics and more. "M2N has been developing and manufacturing MEMS based microneedles with NanoPass for more than 14 years. It's an amazing thing considering the average lifespan of a company in recent years. During this long period of time, we have built a strong business relationship on the basis of trust. We are excited to provide high quality microneedles to NanoPass as a Prime Manufacturer and to support NanoPass in developing the new business applications as a Strategic R&D Partner." Kyuho Hwang, CEO of Micro2Nano Yotam Levin, MD, CEO of NanoPass, added, "M2N has been a trusted partner for over a decade and has been assisting NanoPass regularly with both its development projects and ongoing commercial production. M2N provides ongoing high-quality products, has a quick response time, and finds ingenious ways to solve complex problems. For us, trust is a key parameter for any partner, and M2N's organizational culture provides just the thing." About M2N M2N has been providing MEMS foundry service since its foundation in 2000. Profound experience and knowhow with MEMS processes enables M2N to co-work with multiple companies for developing new products and provide mass production services based on MEMS technology. Additionally, M2N has developed its own product line including MEMS probe cards for semiconductor wafer testing and MEMS sensors. About NanoPass NanoPass is a pioneer in the development and commercialization of microneedle-based delivery platforms for aesthetics, vaccines and more. MicronJet®600 is FDA 510k cleared, CE marked and has regulatory approval in Russia, Brazil, South Korea, China and more. It is supported by extensive clinical data and approved for the delivery of any substance or drug under the surface of the skin that is approved for this delivery route.

Read More

RESEARCH

Two Labs, an Envision Pharma Group Company Acquires Riparian

Two Labs | July 08, 2021

Two Labs, an industry-leading pharma services company and a subsidiary of Envision Pharma Group, announced today the acquisition of Riparian, a pharma consulting and SaaS company that assists manufacturers with pricing regulations, reporting, strategies, and program operations. The acquisition expands Two Labs' pharma service offerings, allowing the company to offer greater insights into the financials associated with drug launch and management, better positioning manufacturers for long-term success. In addition, Riparian's in-depth knowledge of government pricing regulations and program operations, combined with their consulting, business process outsourcing, and software capabilities, enables clients to understand the financials of their drug better, ensuring that the prices reported to the government are in accordance with the current government statutes and regulations. Riparian and Two Labs will collaborate to accelerate parent company Envision Pharma Group's plans for expansion in the growing biotech pharma sector in the United States. In November 2020, Envision acquired Two Labs. Riparian will continue to operate from its current headquarters in Henderson, Nevada, with offices in Pasadena, California, and Johnson City, Tennessee. In addition, David Chan and Cynthia Hwang, co-founders, will continue with the company. About Two Labs Two Labs is a leading pharmaceutical services company that offers pharmaceutical manufacturers a range of market access, market intelligence, and commercialization services. Two Labs has managed over 200 new product launches and over 290 in-market projects from pre-launch through loss of exclusivity since its start in 2003. About Envision Pharma Group Envision Pharma Group, founded in 2001, is a global, innovative technology and scientific communications company that serves pharmaceutical, biotechnology, and medical device companies. Envision is a leading provider of evidence-based communication services and industry-leading technology solutions (iEnvision) with applications in various areas of medical affairs and related functional responsibility. Envision Pharma Group serves over 90 companies, including all top 20 pharmaceutical companies, with services and technology solutions. About Riparian Riparian is a pharma Consulting, Outsourcing, and SaaS company based in Henderson, Nevada, assisting manufacturers in navigating government pricing regulations, reporting, strategies, and program operations. Riparian is a rapidly growing, innovative company supported by a team of industry experts.

Read More