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Federal Policy
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Virginia Bio works effectively on a range national policy issues impacting our members and our industry because of our close working relationship with leading national organizations BIO, PhRMA, MDMA and AdvaMed. The skilled and experienced staff at these Washington-based organizations 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

 

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.

 

Virginia Bio throughout the year provides information and responds to requests for information from legislative and executive policy makers, and helps put them in touch with our members in networking events, and forums and one on one. 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.

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).

The Federal issues that we are currently monitoring and advocating can be found here. We also need your help with contacting your legislators to communication your position. We will continue to update this page as the status changes or if new issues arise.


21st Century Cures

Virginia BIO strongly supports H.R. 6, the 21st Century Cures Act, which passed the House of Representatives in July. The legislation encourages innovation in the development of therapies for both prevalent and rare medical conditions.

The legislation will bring patients prominently into the drug and treatment development process by requiring patient input during both the development and regulatory stages during review.

The legislation also encourages innovation in precision medicine in the laboratory industry. Ultimately, the 21st Century Cures Act will allow for the development of more innovative, precise treatments for patients, which will increase the quality and efficiency of our healthcare system.

The Senate has been slower to address these issues, and is doing so in, S. 2188, the Rare Disease Innovation Act. However, that bill is not as broad or ambitious as H.R. 6.

Please tell your Members of Congress we support these measures.

Click here for more information.


Patent Reform

Virginia Bio opposes H.R. 9, the Innovation Act.

The bill will jeopardize our leadership in biotech innovation. While reforms are important, those reforms need to be targeted at abuse in a balanced way.

Instead of maintaining balance, the legislation goes beyond just punishing patent trolls, and makes things more difficult for all patent owners. The focus should be on including and enhancing transparency of patent ownership and enforcement; curtailing unfair or deceptive practices in the indiscriminate sending of patent licensing or settlement demand letters; and provisions that address how patents can be enforced against innocent end-users or consumers of infringing products manufactured and sold by others. The bill has been championed by Chairman of the House Judiciary Committee, Virginia’s Bob Goodlatte (R) (VA- 6).

Significant changes are necessary to protect innovation and the vast benefits that come with a thriving biotech industry.

The Senate again lags the House in moving legislation, however, S. 1137, the PATENT Act shows a better balance of interests and addresses some key harmful issues that exist in H.R.9.

Please urge Chairman Goodlatte and your Virginia House members to amend the bill to the realities of the bioscience innovation industry, and indicate support to your Senators for the attempt to make appropriate accommodations in this area.

For more information see H.R. 9 and S. 1137.


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. Disrupting how the care of these patients is delivered and paid for would do a great disservice to the sickest patients fighting devastating diseases.

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.

While no specific legislation is pending to cut Medicare Part B, it is always vulnerable.

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

For more information see this primer on Medicare Part B.


Medicare Part D

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

The marketplace negotiation mechanism built into the Medicare Part D program (the prescription drug component of Medicare) at its inception has proved to be one of the most successful pieces of health public policy in decades, resulting in program costs far below original OMB estimates while providing the full range of drugs demanded by patients. 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.


Find and/or contact Virginia Senators or Representatives


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