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Three senators are asking the US Government Accountability Office (GAO) to investigate potential abuses of the Orphan Drug Act, reported Kaiser Health News. Sens Orrin Hatch (R-UT), Chuck Grassley (R-IA), and Tom Cotton (R-AR) sent a letter to the GAO raising the possibility that regulatory or legislative changes may be needed to “preserve the intent of this vital law.” In the letter, the senators wrote, “While few will argue against the importance of the development of these drugs, several recent press reports suggest that some pharmaceutical manufactures might be taking advantage of the multiple designation allowance in the orphan drug approval process.” The senators asked for a list of drugs that were FDA-approved and denied orphan status, as well as whether resources at the agency have kept up with the number of requests from drugmakers and whether there is consistency in the department’s reviews, KHN reported.
On Monday, House Republicans released the proposal to repeal and replace the Affordable Care Act, but conservative lawmakers and activist groups threaten to sink the bill, The Wall Street Journal reported. White House officials said they were unfazed by the criticism, and negations could help resolve lingering objections from lawmakers. President Donald Trump announced his full support of the replacement plan saying, “We’re going to do something that’s great and I’m proud to support the replacement plan released by the House of Representatives. “We’re going to take action. There’s going to be no slowing down. There’s going to be no waiting and tno more excuses by anybody.”
The newly-released replacement plan for the ACA could create a major shift in taxes for low and middle income individuals while delivering a big tax break to the wealthy, according to The Washington Post. Republicans have heavily criticized the ACA for creating a new system of tax credits based on income levels to help individuals buy health insurance or establish health care exchanges. The new plan replaces the credits with tax subsidies, based on age and income, that are intended to make it easier to buy insurance on the private market, according to the Post.
FDA Approves Bimekizumab-Bkzx as Treatment for Hidradenitis Suppurativa