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Drug Pricing

July 27, 2018 |

FDA aims to reform the clinical trial space in a way that could help bring more second- and third-in-class drugs to the market, FDA Commissioner Scott Gottlieb told lawmakers on Wednesday (July 25).

July 27, 2018 | Daily News

FDA aims to reform the clinical trial space in a way that could help bring more second- and third-in-class drugs to the market, FDA Commissioner Scott Gottlieb told lawmakers on Wednesday (July 25).

July 27, 2018 | Daily News

FDA soon will make public information about how it could improve its Expanded Access program, based on an assessment by an outside company, FDA Commissioner Scott Gottlieb said at a House Energy & Commerce health subcommittee hearing Wednesday (July 25).

July 27, 2018 | Daily News

FDA finalized plans Thursday (July 26) to stop granting orphan-drug designations, which come with seven years of exclusivity, to drugs for pediatric subpopulations of common diseases.

July 27, 2018 | Daily News

Stakeholders are set to debate Sept. 4 whether FDA's so-called umbrella exclusivity policy will apply to biologics and biosimilars.

July 25, 2018 | Daily News

CMS sent a memo Tuesday (July 24) asking Part D plans to do all they can to push generics as alternatives to higher-costs brands, following a tweet from HHS Secretary Alex Azar asking CMS chief Seema Verma to examine how Part D plans could do more to push low-cost generics.

July 25, 2018 | Daily News

The Senate health committee unanimously advanced Wednesday (July 25) a bipartisan bill to ban so-called gag clauses in exchange and private insurance plans. A last-minute addition to the bill also would give the Federal Trade Commission more visibility into potential pay-for-delay agreements between biologic and biosimilar makers.

July 09, 2018 |

The brand drug lobby explained in a July 2 blog why it believes the Trump administration’s proposal to force plans to share rebates at the point of sale would not interfere with price negotiations between brands and plans.

July 05, 2018 | Daily News

The House Energy & Commerce Committee unveiled a number of draft 340B reform bills it will take up along with seven pending 340B bills at a health subcommittee hearing Wednesday (July 11), and while some of the draft legislation was expected, such as discussion drafts to change the definition of a patient and give the Health Resources and Services Administration more authority, one attorney said others appear to be messaging bills or focused on very narrow concerns.

July 05, 2018 |

The House Energy & Commerce Committee unveiled a number of draft 340B reform bills it will take up along with seven pending 340B bills at a health subcommittee hearing Wednesday (July 11), and while some of the draft legislation was expected, such as discussion drafts to change the definition of a patient and give the Health Resources and Services Administration more authority, one attorney said others appear to be messaging bills or focused on very narrow concerns.

June 28, 2018 | Daily News

The brand drug lobbies dropped Thursday (June 28) their lawsuit against Nevada’s insulin-price transparency law.

June 28, 2018 |

The brand drug lobbies dropped Thursday (June 28) their lawsuit against Nevada’s insulin-price transparency law.

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 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 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

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

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.

June 15, 2018 | Daily News

Congressional advisers for Medicare and Medicaid sent their June 2018 reports to Congress Friday (June 15) with expected recommendations on reducing Medicare payment rates for some emergency departments and strengthening the Medicaid Drug Rebate Program.

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