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#SaveJosh Campaign Inspires Legislation

January 26, 2015

By Morgan White
Capital News Service

RICHMOND – Josh Hardy, a Fredericksburg boy battling a rare disease, has inspired state Sen. Bryce Reeves to sponsor legislation making it easier for terminally ill patients to obtain investigational drugs that have not yet been approved by the U.S. Food and Drug Administration.

Reeves, who represents Fredericksburg and areas west of the city, filed Senate Bill 1222 as a result of the Hardy family’s successful social media campaign to gain access to brincidofovir, an experimental antiviral drug. About 17,500 people signed an online petition supporting the campaign.

“Josh Hardy’s brother plays on my lacrosse team, so I know the family really well in the sense of the challenges and tribulations this poor family has gone through,” Reeves said.

He said his bill would help terminally ill patients when experimental medication is available but the drug has not been approved for commercial use.

“(If) there’s a drug out there that can do some good and these folks voluntarily do it, then we should try to make that access available,” Reeves said.

SB 1222 is awaiting consideration by the Senate Education and Health Committee. Reeves said he does not anticipate opposition to the proposal.

If the General Assembly
passes the bill, the manufacturer of an investigational drug may make it available to a terminally ill patient when no comparable alternative treatment options have been approved by the FDA.

The bill stipulates that the potential benefits of the drug must outweigh the risks of its use. Also, the patient or legal guardian must provide informed written consent to use the investigational drug, biological product or device.

The pharmaceutical company could provide the drug for free or could charge for it, under the bill. It would not require insurers to cover the costs of investigational drugs or products.

Josh Hardy, 8, was diagnosed with myelodysplastic disorder, a precursor to leukemia if left untreated, in the fall of 2013.On Jan. 10, 2014, Josh received a bone marrow transplant.

While he was recovering at St. Jude Children’s Research Hospital in Memphis, Tenn., Josh contracted an adenovirus infection. The infection can be fatal if the patient has a weak immune system.

To treat the infection, Josh’s family sought brincidofovir, which was developed by Chimerix, a biopharmaceutical company in Durham, N.C. The company initially said it couldn’t give Josh the drug because it hadn’t been adequately tested in clinical trials and approved by the FDA.

That was what prompted the #SaveJosh campaign, which drew support from people around the world. Chimerix subsequently provided brincidofovir to Josh as the first patient in a pilot trial approved by the FDA. He responded well to the drug and has been doing better.

Reeves represents the 17th Senate District, which includes Fredericksburg and Orange County and parts of Spotsylvania, Albermarle, Culpeper and Louisa counties.

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More on the Web

Josh Hardy and his family keep an online journal at http://caringbridge.org/visit/joshuahardy

To monitor or comment on Senate Bill 1222, visit the Richmond Sunlight website, www.richmondsunlight.com/bill/2015/sb1222/