The 21st Century Cures Act passes through the House with resounding support

The 2st Century Cures Act, a nearly 1,000 page bill that details changes for the Food and Drug Administration (FDA) and National Institute of Health (NIH), passed by a vote of 392-26 today in in the House of Representatives. A Senate vote could come as soon as next week.

Assuming the bill prevails in the Senate, the NIH will be the recipient of $4.8 billion in funding over the next 10 years, though money allocation must be reauthorized each year. This money is “earmarked for the three landmark big science initiatives of President Obama’s time in office: the cancer moonshot, the BRAIN Initiative, and the Precision Medicine Initiative” (FierceBiotech).

The passing vote of 392-26 came as a shock to some critics of the bill, “showing a bipartisan spirit that has been rare in recent years” (statnews.com). If the bill passes, it would also “gives states $1 billion to fight the opioid crisis, and deliver an additional $500 million to the FDA.”

FDA’s list of emerging tech requests topped by continuous manufacturing and sterile production innovations

The US FDA’s Emerging Technology program was established as a catalyst for new technologies to help modernize pharmaceutical development and manufacturing in areas where the FDA has limited review or inspection experience. Thomos O’Connor from the FDA’s Office of Pharmaceutical Quality explains that “this is technology with the potential to modernize the body of knowledge associated with pharmaceutical development to support more robust, predictable, and cost-effective processes or novel products… our vision is to have a maximally efficient, agile, flexible pharmaceutical manufacturing  sector that reliably produces high quality drugs without extensive regulatory oversight ” (in-PharmaTechnologist.com).

O’Connor is a member of the committee formed to facilitate the program and assist the industry with applications. The committee, known as the Emerging Technology Team (ETT), has already received 20 applications this year, doubling the number requested last year. The in-PharmaTechnologist article breaks down the submissions: continuous manufacturing technologies for drug product, substance, and biologics represent 30% of all requests, another 30% consists of the use of robotics and container closure systems for sterile injectable production, biotechnology processes and analysis represent 22%, and the final 17% include other areas of innovation such as new dosage forms and 3D printing.

What implications, if any, do these numbers say about the future of the life sciences industry? One could look at the breakdown as a compass for where future demand (and funding) will be. Though continuous manufacturing and robotic/container closure technologies led the way with a majority share of submissions, the numbers represent a fairly even and robust spread of emerging technologies. If your firm is looking to participate in the Emerging Technology program and need guidance with your IND, NDA, ANDA, or BLA application, our dedicated team of experts at Pearl Pathways is here to help.

FDA Halts Finalization of Lab-Developed Test Draft Guidance

Last Friday, the FDA halted the finalization of guidance that would have changed the way lab-developed tests (LDTs) are regulated. The reason? The presidential election. The current administration now enters its waning hours and the FDA decided to suspend guidance until the new regime takes office.

As RAPS reported, the press office for the FDA, Tara Goodin, defended this position because the “FDA believes that patients and health care providers need accurate, reliable, and clinically valid tests to make good health care decisions – inaccurate or false tests results can harm individual patients. We have been working to develop a new oversight policy for laboratory developed tests… and realize just how important it is that we continue to work with stakeholders, our new Administration, and Congress to get our approach right. We plan to outline our view of an appropriate risk-based approach in the near future.”

The agency released draft guidelines two years ago outlining a risk-based framework for regulating LDTs that would be phased in over nine years. LDTs have historically been regulated by the Centers for Medicare & Medicaid Services under the Clinical Laboratory Improvement Amendments. The FDA’s decision, though praised by some, creates uncertainty for the industry and may leave a lot of companies in limbo. To learn more about this topic, see our industry whitepaper. Need assistance navigating the regulatory guidance for IVDs or LDTs, contact us and our experts can help.

Gretchen Bowker to lecture at Tools & Techniques in Translational Research course

new-ctsi-logoOn November 22nd, Pearl Pathways COO, Gretchen Bowker, MS, RAC, FRAPS will lecture on the topic “Drug Development:  Goin’ to the FDA” for the Indiana Clinical and Translational Sciences Institute (CTSI) Fall 2016 course – Tools and Techniques in Translational Research. The course is designed to provide an understanding of the basic technologies and techniques used in translational research today. Translational Research is the application of basic discovery to human health and disease. Bowker is one of the faculty lecturers helping Purdue, Notre Dame and IU Bloomington advanced graduate students, clinical and research based postdoctoral fellows gain the skills needed to succeed in translational research. Check out Indiana Clinical and Translational Sciences Institute (CTSI) to learn more about their role in accelerating clinical and translational research.

FDA awards $23 million in grants to Orphan drug development

On October 17th, FDA announced that over $23 million in grants will be given to 21 new clinical trial research grants for development work in new therapies/devices for rare diseases over the next four years.  The grants were awarded through the Orphan Products Clinical Trials Grants Program.

“We are proud of our 30-year track record of fostering and encouraging the development of safe and effective therapies for rare diseases through our clinical trials grant program,” said Gayatri R. Rao, M.D., J.D., director of FDA’s Office of Orphan Product Development, within the Office of Special Medical Programs. “The grants awarded this year will support much-needed research in 21 different rare diseases, many of which have little, or no, available treatment options.”

Take a look at the press release to see a list of the grant recipients and a description of the study. Need assistance in managing your orphan drug designation or regulatory filing? Contact Pearl Pathways for an experienced team in orphan products.

FDA is building NEST for medical device

Jeffrey Shuren, M.D., J.D., Director of FDA’s Center for Devices and Radiological Health recently posted an article on the FDA Voice stating that the FDA is examining the ways they work with hospitals regarding data collection for medical devices. Hospitals can contribute to the safe use of medical devices by participating in the National Evaluation System for health Technology (NEST).

NEST is being built to look at evidence across the total product lifecycle of medical devices — excellent information to be passed along to patients. Need assistance with your post market surveillance program? Contact Pearl Pathways to partner with you.

Listen to the patient and learn

Theresa Mullin, Ph.D. and Director of FDA’s Office of Strategic Programs in the Center for Drug Evaluation and Research recently posted a blog on FDA Voice updating about the progress that has been made in the effort to listen and capture patient perspectives on the impact of their conditions on their day to day lives.  On September 27th, the FDA held the 20th Patient Focused Drug Development (PFDD) meeting — a milestone meeting in the important work of listening to the patient.  Patient perspective is valuable information in drug development and is a priority for FDA, healthcare providers and industry.  Hearing from the patient community, their families and caregivers is important knowledge that will allow all to do their jobs even better in drug development, in reviews and in making decisions.  Take a look at the Voice of the Patient Reports for an in-depth look at how disease impacts daily lives.  It is a very important perspective to understand.

FDA wants your data…

Pharma groups use quality metrics to monitor their own quality and identify areas to improve.  FDA will soon be requesting this valuable data and making use of it – a revision to the FDA’s draft guidance on quality metrics is planned still for 2016.

FDA plans to use this data “…to help develop compliance and inspection policies and practices, such as risk-based inspection scheduling of drug manufacturers; to improve the Agency’s ability to predict, and therefore, possibly mitigate, future drug shortages; and to encourage the pharmaceutical industry to implement state-of-the-art, innovative quality management systems for pharmaceutical manufacturing.”

Check out this article where Zachary Brennan, RAPS, summarizes a list of the types of data the agency will be looking for.

 

Looming deadline for manufacturers of antibacterial wash

Final ruling from the FDA was released on 9/6 that gives manufacturers of consumer antibacterial wash one year to remove 19 banned ingredients from their products.  The ingredients are not generally recognized as safe and effective and consumer antibacterial washes containing these will be considered misbranded effective 1 year after final rule publication in the Federal Register and cannot be sold.  Companies can submit for new drug applications which will be required for marketing, remove from the market or reformulate their products.  Read more in Zachary Brennan’s article on RAPS and in the Final Rule.

Need help in complying to this final rule?  Contact Pearl Pathways.

UDI deadline extended for products with NHRIC and NDC codes

Unique Device Identifier (UDI) provision implementation is proving to be a large undertaking — a project involving many dependent tasks with multiple stakeholders including supply chain, pharmacies and payers.  “The UDI Rule, established in the Food and Drug Administration Amendments Act of 2007 (FDAAA), includes a provision that rescinds any NHRIC or NDC number assigned to a device.”  The extension to 2021 is being allowed to avoid possible disruption that could interfere with patient access to devices.  The extension was made based on feedback from industry — the guidance released on August 30th indicates that “FDA has revised the guidance to reflect the Agency’s intent not to enforce the prohibition against providing National Health Related Item Code (NHRIC) and National Drug Code (NDC) numbers on device labels and device packages, with respect to finished devices that are manufactured and labeled prior to September 24, 2021.  We expect the UDI labeling requirements will be fully implemented by September 24, 2021.  We also believe additional time is appropriate for stakeholders to adopt medical device reimbursement, supply chain, and procurement systems, which do not depend on having an NHRIC or NDC number on the device label.”  Zachary Brennan reports additional information on this topic in his informative article on RAPS.

Need help ensuring your company’s UDI compliance?  Contact Pearl Pathways to start the discussion of how we can help your team.