FDA looks to foster generics competition
In an effort to bring down the price of prescription drugs, the Food and Drug Administration’s new commissioner, Dr. Scott Gottlieb, has made increasing competition among generics manufacturers one of his top priorities. Gottlieb unveiled the Drug Competition action plan in late June. Ahead of a July 18 public meeting, the agency released a list of branded drugs that currently have no listed patents or exclusivities, and also have no generics.
The list came with a new policy to expedite review of applications for generics of products with limited competition. The FDA also has pledged to expedite the review of applications until a given product has three generic equivalents.
And with the goal of creating a guidance later this year on best practices for manufacturers on submitting abbreviated new drug applications — to be paired with an internal Manual of Policies and Procedures on how best to assess submitted ANDAs — the FDA held a public meeting on July 18, kicking off a two-month comment period during which stakeholders are encouraged to share their input on how best to improve generic competition and what current barriers exist.
Gottlieb has identified some of the barriers he sees to competition, which he said includes efforts by branded drug makers to slow generics development. Among the barriers he identified were making branded products unavailable for comparative testing, as well as restricting commercial contracts with distributors to make it difficult for intermediaries to sell to generics developers. He also pointed to the difficulty some companies have in accessing medications under limited distribution — either voluntary or through a Risk Evaluation and Mitigation Strategy.
CVS Health VP of policy and regulatory affairs Donald Dempsey, in his comments to the FDA on behalf of CVS Health, noted that the FDA could address the problem of REMS abuse by clarifying that FDA approval isn’t required for a generic maker to access samples from the manufacturer for the purpose of bioequivalence studies. Dempsey also said that finalizing a draft guidance from Decemeber 2014 stating an FDA letter wasn’t a legal requirement to access samples of a drug with an REMS would be a step forward.
“It is estimated by the Association for Accessible Medicine that misuse of REMS to prevent competition costs the healthcare system more than $5 billion every year,” Dempsey said. “While REMS are by law not supposed to restrict competition, the reality is that it is a common way for drug manufacturers to delay competitors.”
The Healthcare Supply Chain Association noted that one element its members see as a barrier is “pay for delay” practices, by which branded drug makers pay the maker of their first generic to wait before entering the market.
“This lack of competition delays patient access to cheaper alternatives. HSCA supports a legislative solution (S.124, Preserve Access to Affordable Generics Act) that would eliminate the tactics that allow brand-name manufacturers to prevent or delay generic manufacturers from entering the marketplace,” HCSA said.
HCSA also noted that the FDA’s backlog is an issue that delays the introduction of generics. At the public meeting, Gottlieb acknowledged that the process can sometimes take a while, highlighting that most ANDAs require four review cycles to reach approval.
In addition to the guidance on best practices aiming to remedy this, Gottlieb said that the second version of the Generic Drug User Fee Amendments, currently awaiting Congressional approval, contains a provision that would increase frequency and scope of FDA communication with applicants. It also would create a pre-ANDA program with a focus on complex generics, ensuring that applications for such medications are complete upon their initial submission. The goal, Gottlieb said, is to keep the FDA as the “gold standard” while working to keep prices low for consumers.
“These improvements will increase efficiency and output, [and] will also free up program staff to communicate more with applicants,” Gottlieb said. “It will also give us more time to engage in more strategic, value-added policy and scientific initiatives.”
Lupin, Natco Pharma get FDA approval for Fosrenol chewable generic
SILVER SPRING, Md. — The Food and Drug Administration has approved Lupin’s and its alliance partner Natco Pharma’s generic of Fosrenol (lanthanum carbonate) chewable tablets, the companies announced Monday. The two companies joined together in 2008 to jointly commercialize this product, which is the first generic of Fosrenol chewable tablets.
“We are very happy to finally be able to launch Lanthanum Carbonate Chewable Tablets in partnership with Natco,” Lupin managing director Nilesh Gupta said. “Lupin’s proven IP capabilities, marketing reach and expertise coupled with Natco’s solid development and manufacturing abilities make a great combination.”
The drug is indicated to reduce serum phosphate in patients with end-stage renal disease. The companies’ generic will be available in 500-, 750-mg and 1000-mg base dosage strengths. For the 12 months ended June 2017, the drug had U.S. sales of $122.4 million, according to QuintilesIMS data.
Walgreens creates health and wellness research depot with new website
DEERFIELD, Ill. — Walgreens on Tuesday announced the launch of its Center for Health & Wellbeing Research, a website that features more than 50 Walgreens outcomes studies completed over the past six years. Areas of research include access to care and patient experience, adherence and clinical outcomes, digital health and member engagement, health care costs, HIV and specialty pharmacy, vaccinations and more.
“We are thrilled to be unveiling the Walgreens Center for Health & Wellbeing Research,” stated Harry Leider, chief medical officer and group VP, Walgreens. “Our goal is, through scientific research, to help improve patient care and outcomes while lowering health care costs. We are dedicated to providing value to health care on a national scale and the Walgreens Center for Health & Wellbeing Research will showcase the work we are doing every day to advance that mission.”
Visitors to the site will find summaries, links and original documents related to company research reports and studies that have been published in peer-reviewed medical and health care publications, as well as presented at scientific and industry conferences.
Walgreens is working with academic institutions on its research, including Johns Hopkins Medicine and the Johns Hopkins Bloomberg School of Public Health, the Scripps Translational Science Institute, the University of California, San Francisco – School of Pharmacy and the University of Chicago Medicine. The institutions provide guidance, specialized expertise and industry insights that contribute to the Walgreens outcomes research agenda. Researchers from Walgreens and these institutions actively collaborate on a variety of research studies.
“Walgreens has been a valued partner in a long-standing and productive collaboration, which has given our clinical and research faculty the opportunity to develop, implement and evaluate novel programs to reach patients where they are to improve their access to quality care,” said Jeanne Clark, a professor of medicine at the Johns Hopkins University School of Medicine and the Johns Hopkins medical director for its collaboration with Walgreens. “We are looking forward to continuing our work together.”
The Walgreens Center for Health & Wellbeing Research is led by a team of more than 25 Walgreens health services researchers, clinicians, statisticians, public health practitioners, actuaries and data scientists.