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MichBio | June BioLink

July 7, 2020

Michigan Business Network

Welcome to the NEW AND IMPROVED BioLink – MichBio’s monthly newsletter!

In this edition you will find – for the first time:

Current advocacy information at the State and Federal levels
A highlight of one of our BIO Business Solutions vendors
Access to recently recorded virtual events
New member spotlight
An introduction to a new member consultant

in addition to the already great featured information, member news, and upcoming events sections.

Reply and let us know what you think of the new look and feel.

As always – thank you for your work and your continued dedication to improving the health and well-being of the people in Michigan and around the globe.

Does Your Company Meet This Description?

A startup focused in the Technology sector
Plan to raise a Seed or Series A round of $1MM-$10MM within the next 3 to 6 months
Have a developed MVP at a minimum
Primary office based in the Midwest (IL, IA, IN, OH, MI, MO, MN, WI, KY)

Then you may be eligible to take part in a cohort of companies being assembled by Silicon Valley Bank to participate in their Virtual Investor Trek for Midwest-based companies. You must apply by FRIDAY, JULY 10th for the event help August 10th – 14th

LEARN MORE AND APPLY

Help Establish the Center for Secured Computation for Drug Discovery and Repurposing – Deadline July 31

The need to get drugs to market faster has never been greater in light of the COVID-19 pandemic. The University of Michigan’s Institute for Data Science (MIDAS) is submitting a proposal to the National Science Foundation’s Industry-University Cooperative Research Centers (IUCRC) program to establish The Center for Secured Computation for Drug Discovery and Repurposing (SCDDR).

Their goal is to create a center where cutting-edge data science research is used to address pain points in the pharmaceutical and biotech industries. In order for the Center to be a success, THEY NEED YOUR INPUT in the planning phase over the next year. If you are interested in having a seat at the table, please provide a Letter of Interest to Jonathan Gryak (gryakj@med.umich.edu), Senior Scientist at MIDAS by July 31.

LEARN MORE

The FDA requests your input for the 21st Century Cures Act Report – Section 3060(b)

The U.S. Food and Drug Administration (FDA) is requesting your input on patient safety, including best practices to promote patient safety, education, and competency, associated with the medical software functions excluded from the device definition by the Cures Act for inclusion in a report to the public. Software functions excluded from the device definition include:

administrative support for health care facilities
encouragement of healthy lifestyles
electronic patient records
transferring, storing converting formats, or displaying data
providing limited clinical decision support

VIEW THE REQUEST FOR INPUT

The Cures Act, signed into law on December 13, 2016, is designed to help accelerate medical product development and bring innovation and advances to patients who need them faster and more efficiently. On September 27, 2019, the FDA issued the guidance Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act with the most current interpretations of the medical software provisions in the Cures Act.

Your input must be submitted by July 30, 2020 to help the FDA develop a report that includes your feedback on the risks and health benefits of the software functions excluded from the device definition by the Cures Act.

SUBMIT COMMENTS

Advocacy at the Federal Level

MichBio Signs Letter Urging CMS to Cover FDA-Approved Breakthrough Devices. MichBio signed on to a letter to the Centers for Medicaid & Medicare Services (CMS)/U.S. Department of Health & Human Services, organized by the Advanced Medical Technology Association (AdvaMed).

The letter, signed by 26 state affiliate organizations, urges the Agency to provide coverage for medical devices that have received breakthrough designation by the FDA. The CURES Act (spearheaded by our very own Rep. Fred Upton), established a breakthrough pathway for regulatory review at the FDA, but there is no similar expedited pathway for payment coverage/reimbursement. This has placed many innovative medical devices in limbo for several years as they wait for a CMS coverage decision.

VIEW THE LETTER

MichBio Joins BIO and Other Industry Partners to Oppose ACA Enhancement Act. The U.S. House of Representatives passed H.R. 1425, the Patient Protection and Affordable Care Enhancement Act, by 234-179, with 2 Republicans voting ‘yes’ and one Democrat voting ‘no’. While the underlying bill seeks to expand health insurance coverage through additional funds for reinsurance, to provide funds to states to expand Medicaid, to eliminate short-term duration plans and others, the offsets come from Title I of H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act. These provisions would allow for HHS to “negotiate” with a manufacturer a maximum price for a drug or be subject to an excise tax, and an international pricing index which would cap prices for certain drugs based on a handful of referenced foreign countries. Failure to comply with the cap would permit additional tax penalties.

The four-hour debate ran as expected with ACA related political punches. Democrats emphasized the Administration’s sabotage of the Affordable Care Act while Republicans defended their support for Americans with preexisting conditions and the need to return to bipartisanship and pass H.R. 19, Lower Costs, More Cures Act of 2019, a compilation of bipartisan policies that passed authorizing committees in early 2019.

House members were reminded of the devastating nature of H.R. 3 policies with materials recirculated by our national partner, BIO, from the debate last fall. These included the following:

1) Small biotech letter with 138 companies opposing H.R. 3;

2) Investor letter opposing H.R. 3; and

3) State bioscience associations letter opposing H.R. 3.

Ways & Means Ranking Member Kevin Brady (R-TX) entered the three letters into the record.

The Motion to Recommit, which failed 187-223 with 9 Democrats voting in favor, would require that the Secretary of HHS, in coordination with FDA, NIH, and the NIAID, certifies that no provision of the bill will adversely affect the research and development of any drug or vaccine intended to treat or prevent infection related to COVID-19.

MichBio has spoken repeatedly with Michigan’s Congressional delegation about policy positions that would adversely impact the biopharma/biotech sector. As an industry, we realize that healthcare costs, especially drug prices, are of great concern for most Americans. However, solutions to lower costs should not be done on the backs of innovative research and development and instead, should focus on reducing patient out-of-pocket expenses.

Advocacy at the State Level

The legislature has recessed for summer break. The next scheduled session days are in late July.

Just before the break, the legislature and Governor reached an agreement to balance the state 2020 budget after a sharp drop in state revenues resulting from the coronavirus pandemic.

The plan to balance the budget relies on a mixture of spending cuts, the use of close to $1 billion in federal coronavirus relief money, and use of $350 million from the state’s Budget Stabilization Fund, better known as the Rainy Day Fund, which has a balance of more than $1 billion.

Allocations come from the federal Coronavirus Relief Funds and will support Michigan businesses to the tune of $150 million; other funds will be used towards schools, universities/colleges, local governments, public health emergency response, public safety, hazard pay for public safety employees, health care workers and teachers.

Drug and Medical Price Transparency. The Michigan House Health Policy Committee, chaired by Rep. Frank Vaupel (R-Howell), held a hearing on the high cost of health care, starting with prescription drugs. The original intent was to introduce a 10-bill legislative package targeting various facets of the pharmaceutical costs supply chain, most notably biopharma companies, but the action was not taken at the last minute. The so-called drug price transparency bill would require companies to track and disclose annually their research and development costs, clinical development costs, and marketing and manufacturing expenses, for each therapeutic, whether developed within their own pipeline or through acquisition.

MichBio has opposed such legislation, as it has at the federal level, for fear of the impact it might have on operational costs, proprietary information protection, and business competitiveness. The legislation has been pending for over a year in one form or another. The latest incarnations are revisions following attempts by the Chair to listen to all effected stakeholders; though the drug pricing legislation remains largely unaltered and took little into account from a list of biopharma sector concerns. The issue of fair drug pricing is not one that will go away soon and continues to receive broad, even bipartisan interest.

Your Voice is Important

You can help keep decision-makers informed on the needs of the bio-industry and help support business-friendly policies that allow for continued growth and development of tools and technologies that improve and save lives. Use the link below to send us an email and find out how you can help.