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Rx Drugs

June 28, 2018 | Daily News

Hospital groups are already pushing back on Rep. Chris Collins' (R-NY) move to create a 340B user fee program, which both the Obama and Trump administration have proposed, saying the Health Resources and Services Administration shouldn't receive more resources since the agency is not implementing oversight on drug manufacturers and has yet to make the 340B ceiling price website public.

June 28, 2018 |

Hospital groups are already pushing back on Rep. Chris Collins' (R-NY) move to create a 340B user fee program, which both the Obama and Trump administration have proposed, saying the Health Resources and Services Administration shouldn't receive more resources since the agency is not implementing oversight on drug manufacturers and has yet to make the 340B ceiling price website public.

June 28, 2018 | Daily News

FDA is launching two quality metrics-focused initiatives -- meetings and a pilot program -- to garner feedback from drug sponsors and other industry stakeholders about the use of quality metrics to help reform and improve pharmaceutical quality systems and to provide industry with further guidance.

June 28, 2018 | Daily News

Reps. John Shimkus (R-IL) and Tony Cardenas (D-CA) are trying to get leadership to attach their antimicrobial bill to must-pass pandemic preparedness legislation.

June 26, 2018 | Daily News

HHS is rewriting safe harbor guidelines for anti-kickback restrictions to let drug makers base the price of drugs on how well they work, HHS Secretary Alex Azar said Tuesday (June 26), though he also suggested doing away with rebates in Medicare Part D, and some brand lobbyists say those policies are inconsistent with each other.

June 26, 2018 | Daily News

FDA soon will publish a list of surrogate endpoints that have already been used as the basis for drug and biologics approvals, FDA Commissioner Scott Gottlieb told stakeholders Monday (June 25).

June 25, 2018 | Daily News

FDA on Monday (June 25) for the first time granted approval to a marijuana-based drug. The drug, Epidiolex, contains cannabidiol (CBD), a purified substance derived from the marijuana plant. Epidiolex is approved to treat seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in patients ages two years and older.

June 22, 2018 | Daily News

The House overwhelmingly approved a legislative package Friday (June 22) aimed at combating the nation’s opioid crisis, concluding a two-week bonanza of House votes on opioid-related measures that include expanding access to medication-assisted treatment, cracking down on over-prescribers of opioids, increasing telehealth services for treatment of substance use disorder, and encouraging non-opioid pain management techniques.

June 22, 2018 | Daily News

The nation's largest seniors group is urging congressional leaders to resist pressure from both parties, and the drug industry, to undo a Medicare Part D donut hole reform tucked into the Bipartisan Budget Act.

June 22, 2018 |

Sens. Chuck Grassley (R-IA) and Amy Klobuchar (D-MN) are urging the new leadership at the Federal Trade Commission to examine whether pay-for-delay deals are blocking biosimilar competition.

June 21, 2018 | Daily News

FDA announced Thursday (June 21) that the agency is withdrawing a draft guidance outlining the statistical approaches a biosimilar sponsor should use to demonstrate biosimilarity to a reference product.

June 21, 2018 |

FDA announced Thursday (June 21) that the agency is withdrawing a draft guidance outlining the statistical approaches a biosimilar sponsor should use to demonstrate biosimilarity to a reference product.

June 20, 2018 | Daily News

The House of Representatives voted Wednesday (June 20) to allow Medicaid to pay for some substance abuse treatment in large inpatient facilities and to ease privacy restrictions for medical records containing information about substance abuse.

June 20, 2018 | Daily News

The House on Tuesday (June 19) voted 342-13 to pass a bill that would direct FDA to work with drug manufacturers to establish programs to return or dispose of unused Schedule II and III substances.

June 19, 2018 | Daily News

The Health Resources and Services Administration's head of 340B, Captain Krista Pedley, told the Senate health committee on Tuesday (June 19) the agency could use additional authority to, among other things, track how providers currently use 340B savings and to define how those savings should be used.

June 19, 2018 | Daily News

The American Medical Association is pushing for 340B reforms that would increase transparency in the drug pricing program, expand the Health Resources and Services Administration's authority over 340B and extend program eligibility to all practices that show a commitment to serving low-income patients.

June 19, 2018 | Daily News

After initially being blocked by House Republican committee leaders, a proposal to expand the authority of non-physicians to prescribe buprenorphine ended up in the umbrella legislation on opioids that the House will vote on this week because the Drug Enforcement Agency dropped its objections to the proposal, according to a congressional aide.

June 19, 2018 | Daily News

The Senate Finance Committee will hold a hearing on President Donald Trump’s drug pricing plan June 26, the committee announced Tuesday (June 19). HHS Secretary Alex Azar is set to testify.

June 18, 2018 | Daily News

The House of Representatives will continue voting this week on a trove of bills aimed at alleviating the opioid crisis, including controversial measures on Medicaid payments for inpatient treatment, medical privacy for people with substance use disorders and expanded prescribing authority for buprenorphine.

June 18, 2018 | Daily News

Lawyers representing outsourcing compounders are signaling they may sue FDA should it finalize guidance outlining its plans to evaluate whether there is a clinical need to compound a drug using bulk active pharmaceutical ingredients.

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