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Drug Pricing

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FDA announced Thursday (June 21) that the agency is withdrawing a draft guidance outlining the statistical approaches a biosimilar sponsor should use to demonstrate biosimilarity to a reference product.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FDA announced Thursday (June 21) that the agency is withdrawing a draft guidance outlining the statistical approaches a biosimilar sponsor should use to demonstrate biosimilarity to a reference product.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

June 14, 2018 | Daily News

The administration’s clarification that it does not plan to make pharmacy benefit managers act as fiduciaries means the drug channel middlemen don’t have to worry about being exposed to heavy legal liability, Pharmaceutical Care Management Association President and CEO Mark Merritt said.

June 14, 2018 | Daily News

The Senate Judiciary Committee voted Thursday (June 14) 16-5 to advance the highly watched Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act without amendments to the Senate floor, but the path to a floor vote on the bill remains unclear.

June 13, 2018 | Daily News

The Association for Accessible Medicines opposes three amendments being offered by Senate Republicans to the generic industry-supported Risk Evaluation and Mitigation Strategies (REMS) reform bill set to be marked up by the Senate Judiciary Committee Thursday (June 14).

June 13, 2018 | Daily News

American Medical Association delegates on Wednesday (June 13) asked the Justice Department and Federal Trade Commission to monitor insulin-pricing and -rebate practices of drug makers and pharmacy benefit managers, and the AMA plans to release a template for state legislators to reference as they write laws to lower insulin prices and ban so-called clawback fees and gag orders that pharmacy benefit managers impose on pharmacies.

June 13, 2018 | Daily News

Attorneys for both Allergan and Mylan faced pointed questions earlier this month from Federal Circuit judges, who are now tasked with deciding whether Allergan’s sale of its drug patents to a Native American tribe can shield those patents from inter partes review.

June 13, 2018 | Daily News

FDA Commissioner Scott Gottlieb said he is discussing with CMS the possibility of a new license-based reimbursement model for antibiotics that would spare drug makers some of the disincentives that come with antibiotic development, such as the low volume of sales that occur when providers try to use antibiotics sparingly.

June 12, 2018 | Daily News

More than 200 House lawmakers, including 50 Democrats, are urging congressional leadership to undo a recently passed law that makes brand drug makers pay 70 percent of Part D donut-hole costs, but a patient advocate group chided Democrats for their support of the brand-backed measure.

June 12, 2018 | Daily News

Sen. Elizabeth Warren (D-MA) asked 10 major brand drug makers whether they plan to voluntarily lower prices, and none said yes -- and one said it will hike prices this year.

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