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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.

Click here for more information regarding the success of Medicare Part D.

Medical Device 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.

H.R. 160 passed the House in a historic vote on 06/18/2015. However, the bill faces opposition in the Senate. Supporters are looking for opportunities to embody the repeal in any legislative package moving forward.

Please communicate to Senators Warner and Kaine your support for the repeal of the medical device excise tax.
On December 18, 2015 the Congress passed the Path Act and Omnibus appropriations and tax extenders bill that included a two year suspension of the medical device excise tax! It is expected to be signed into law by President Obama.

Click here for more information.

Trans Pacific Partnership

While Virginia Bio generally supports the Trans Pacific Partnership (TPP), we are alarmed that negotiators failed to include 12 years of data exclusivity (the US rule) for biologics in the agreement.

From Biotechnology Industry Organization CEO, Jim Greenwood, “The current 12-year period of exclusivity in the United States was carefully crafted by a bi-partisan majority of the Congress after a thorough and thoughtful debate and deliberation. The Congress set 12 years as the appropriate period to both foster innovation and provide access to biosimilars in a reasonable timeframe. While the TPP agreement will not impact the U.S. data protection period, we believe the failure of our Asian-Pacific partners to agree to a similar length of protection is remarkably short-sighted and has the potential to chill global investment and slow development of new breakthrough treatments for suffering patients.” TPP requires Congressional approval, by a majority vote in both House and Senate.

Click here for more information on TPP.

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. By their terms, they are up for renewal every five years, including 2016.


Virginia Bio supports 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.

We also hope that PDUFA 6 will take into account some of the goals of the 21st Century Cures Act, by integrating a more innovative, patient-centric process into the current regulatory framework.


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


Virginia BIO supports 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.


Virginia Bio supports 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 general been successful.

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

Find and/or contact Virginia Senators or Representatives

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