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Federal Policy
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PURPOSE & GOALS

Virginia Bio works for federal policies that:

● Strongly support basic and translational research, such as the levels and conditions of National Institutes of Health (NIH) funding and SBIR/STTR funding;

● Provide an effective and efficient regulatory framework and a well-equipped and accountable FDA, for example the FDASIA user fee legislation and adequate FDA funding and performance accountability;

● Provide fair reimbursement for drugs, devices and diagnostics and patient access under federal payor programs like Medicare and Medicaid;

● Assure taxes and regulations are sufficient and fair, but do not disproportionately or destructively impact our member companies or their industry, or the innovation ecosystem on which progress in health care rests; and,

● Strengthen and spread meaningful and effective intellectual property protection, including US patent laws and international treaties involving Intellectual Property (IP).
  

OUR PARTNERS

The skilled and experienced staff at the Washington-based organizations listed below help us to stay apprised of issues and events, to participate in the formation and advocacy for specific policies, to provide firm and state level feedback on federal legislative and administrative policy issues, and to help our members make known their positions and concerns.

BIO Government Relations

BioAction

PhRMA

Advamed Issues
Medical Device Manufacturers Association




Virginia Bio organizes the participation of its members in yearly national "fly in” days to Washington, DC for BIO, AdvaMed and the "We Work for Health” coalition.  Participating members travel to Washington and join their counterparts from across the United States in briefings on critical and pressing federal issues. They then visit members of the Virginia Congressional delegation and their staffs to make their voices heard on these issues and issues of individual interest.

We build long term relationships with legislative and executive policy makers with our organization and our members. Year-round, we make visits and invitations to federal policy makers. We assist members in making contact with members of Congress and regulators, and help them get the help they need on individual issues.

 

 

CENTRAL ISSUES

 

1)    Medicare Part B

Medicare Part B coverage of drugs provides an invaluable route of access for patients facing chronic illness. Part B provides an important pathway for patients to access a narrowly defined, limited number of provider-administered products (e.g., those that are injected or infused under the direction of a physician). Furthermore, the patients served under Part B are often the sickest and, therefore, most vulnerable.

Virginia Bio opposes a cut to Medicare Part B, as such a cut will limit healthcare access for the most vulnerable patients in our population.

When you communicate with your Members of Congress, please indicate your support for maintaining Medicare Part B as is. It is always vulnerable, and a perennial concern.

For more information see this primer on Medicare Part B.

 

2)    Medicare Part D

Virginia Bio opposes government intervention in the price structure associated with Medicare Part D benefits.

Proposals to enable the federal government to directly intervene in drug supply and cost negotiations could negatively affect the prices paid for prescription drugs, distort the competitive dynamic of the program and result in a range of unintended consequences, including a significant increase in beneficiary premiums, a negative impact on innovation, and cost-shifting to other consumers.

While no specific legislation is yet pending to interfere with the successful negotiation mechanism now in place for Medicare Part D, there is increasingly a call by opponents to do so, and it is likely soon to be a contested issue.

When you communicate with your Members of Congress, please indicate your support for maintaining Medicare Part D as is.

For more information see this primer on Medicare Part D.

 

3)    Medical Device Excise Tax Repeal

Virginia Bio supports H.R. 160, the Protect Medical Innovation Act, which would permanently repeal the medical device excise tax.

The unnecessary device excise tax - which levies a 3.5% tax on revenues, not profits- stifles innovation by increasing the tax burden of biotech companies - even those in growth mode and making no profit - and requiring them to shift dollars from R&D, workforce development, technology, etc. It is universally regarded as horrible public policy, but deemed a necessity by its remaining supporters to piece together the coalition for the ACA several years ago. Its destructive effect on the US medical device industry far outweighs the benefits.

Click here for more information.

 

 

4)    User Fee Acts

Virginia Bio, along with virtually all of the biopharmaceutical and medical device industry, encouraged and supported the creation of several user fee acts a decade ago, to provide FDA additional resources directly from industry users which would be used hire additional experts and reviewers and strengthen and streamline the review process. By all accounts, these User Fee Acts have been successful, and we continue to support them. They were renewed in 2017 in the FDA Reauthorization Act, which was supported by Virginia Bio.

 

5)    PDUFA

Virginia Bio supported the reauthorization of the Prescription Drug User Fee Act (PDUFA).

To secure the necessary capital and investment to support the development of new therapies, including costly clinical trials, entrepreneurial biotechnology companies require a clear, reliable, and predictable regulatory environment. By providing funds for review enhancements that enhance clarity and predictability, PDUFA helps foster biomedical innovation so patients can benefit from novel therapies without unnecessary delay.

Click here for more information, and to find ways to participate in the discussion.

 

6)    MDUFA

Virginia BIO supporteds the reauthorization of the Medical Device User Fee (MDUFA).

The MDUFA agreements have a history of bringing improvements to the working relationship between the biotech industry and the FDA. We hope the reauthorization of MDUFA will include plans for performance improvements, specifically with regards to review times. Additionally, the last MDUFA agreement included positive direction related to data reporting and FDA/Industry interaction. Virginia Bio supports the continued improvements in these areas.

Click here for more information, and to find ways to participate in the discussion.

 

7)    GDUFA

Virginia Bio supported the reauthorization of the Generic Drug User Fee Act (GDUFA).

GDUFA has fostered improvements in safety, access and transparency that have allowed patients to benefit from generic drugs. Similarly to PDUFA and MDUFA, improvements in the process should be considered, but GDUFA has generally been successful.

Click here for more information, and to find way to participate in the discussion.

 

 



more Events

1/7/2018
Virginia Reception in San Francisco

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