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Drug Pricing

December 06, 2018 | Daily News

To mitigate drug shortages, a not-for-profit generic drug company is proposing FDA, on its own and through collaboration with other government agencies, provide manufacturers with myriad incentives, including: reduced regulatory oversight, increased time between inspections, tax credits or federal grants, and fee waivers for certain generic companies.

November 28, 2018 |

The White House Office of Management and Budget on Tuesday (Nov. 27) began reviewing a final regulation that, as proposed, would move up implementation of the 340B ceiling price and penalties rule to Jan. 1.

November 07, 2018 | Daily News

House Democrats promise to take on drug prices when they take control of the House next year, but the actual likelihood of aggressive measures becoming law depends largely on whether they will work with the president on legislation and, if so, whether the president can get Senate Republican leaders in line. However, President Donald Trump is pursuing administrative changes to lower drug prices that don't require Congress' blessing, and congressional Democrats may find themselves walking a fine line between not wanting to help Trump and delivering on their own promises to lower drug prices.

October 26, 2018 |

Drug pricing reforms are coming soon in a proposed rule separate from the proposed Part D and Medicare Advantage rule issued by Friday (Oct. 26), CMS said in the Part D rule.

October 15, 2018 | Daily News

Brand drug makers are warning against relying on 340B hospitals to execute Louisiana’s plan to pay a subscription for an unlimited supply of hepatitis C drugs over a fixed period.

October 12, 2018 |

Brand drug makers are warning against relying on 340B hospitals to execute Louisiana’s plan to pay a subscription for an unlimited supply of hepatitis C drugs over a fixed period.

October 05, 2018 |

CVS next year will offer a Part D plan that shares drug rebates at the point of sale, and the monthly premium for the plan is $80 in the Washington area, compared to the $32.50 national average Part D premium, though the CVS plan offers more generous benefits than basic drug plans.

October 05, 2018 |

A nonpartisan forum of state policy advisers will hire a consultant next month to help a handful of states create drug price transparency programs, and in turn hopes to develop a plan that other states could use to require price transparency -- an issue likewise central in the national drug-pricing debate.

September 26, 2018 |

The final version of opioid legislation excludes brand-drug industry-backed Part D changes, and now brand lobbyists have set their sights on the lame-duck session for getting Congress to lower the industry’s share of seniors’ drug costs.

September 26, 2018 |

Pharmacists will be allowed to tell customers when it is cheaper to fill prescriptions without insurance after the president signs legislation the House has sent to him banning so-called gag orders.

September 25, 2018 |

Eleni Anagnostiadis on Monday (Sept. 24) began her 120-day detail as director of the FDA drug center’s professional stakeholder and engagement staff, according to an agency announcement.

September 25, 2018 |

Gilead’s decision to make authorized generics of its hepatitis C medications will lower costs for patients who buy drugs without insurance and for Medicaid managed care plans, but it’ll also likely lower Medicaid rebates that states collect.

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.

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