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Drug Pricing

Friday, 23 June 2017

A leaked draft of an alleged White House executive order on drug prices calls for value-based contracts, lower Medicare beneficiary out-of-pocket costs, drug rebate reforms, restricted hospital drug discounts, faster FDA approvals and higher prices in other countries.

Friday, 23 June 2017

Pfizer announced Thursday (June 22) that FDA has rejected its epoetin alfa biosimilar due to good manufacturing practice violations, despite an advisory committee recommending approval last month.

Thursday, 22 June 2017

FDA Commissioner Scott Gottlieb is acting on his promise to congressional appropriators that the agency will hold a public meeting examining potentially anti-competitive actions meant to keep generics off the market.

Wednesday, 21 June 2017

FDA isn't waiting for the generic drug user fee reauthorization measure to move through Congress to move forward with one of the package's commitments: A new draft guidance issued this week sets up a new pre-submission process for certain generic drug applications, which FDA chief Scott Gottlieb says could cut two months off review times and increase access to affordable drugs.

Wednesday, 21 June 2017

House Democrats who met with the president in the spring to discuss drug-price policies are urging him to take aggressive action to curb price increases in an anticipated executive order. However, news reports indicate President Donald Trump is considering measures that are friendly to the drug industry.

Tuesday, 20 June 2017

FDA will create a “Medical Innovation Development Plan” aimed at lowering health care costs by facilitating development of drugs to treat costly rare diseases through improved adaptive trial designs and statistical tools, agency chief Scott Gottlieb announced Tuesday (June 20).

Tuesday, 20 June 2017

Sen. Susan Collins (R-ME) is considering using Medicare Part D as leverage to stop brand drug makers from gaming FDA drug-safety policy to thwart generic competition.

Monday, 19 June 2017

The U.S. Supreme Court agreed last week take up a case that will determine the constitutionality of the patent office’s inter partes review process -- an administrative procedure for challenging patents that some drug industry stakeholders have said undermines the drug pipeline and unfairly uses a lower standard for reviewing patents than that used by a district court.

Monday, 19 June 2017

In the wake of the U.S. Supreme Court's reversal of a lower court decision on patent exhaustion, which some see as partially clearing the way for drug importation, legal experts argue that the pharmaceutical industry will now turn to contract disputes over licensing to fight importation.

Friday, 16 June 2017

President Donald Trump could use an executive order to direct the CMS innovation center to waive rules that would make it easier for drug companies and insurance companies to use value-based contracts, said Paul Howard, director and senior fellow at the Manhattan Institute.

Friday, 16 June 2017

Changing CMS’ controversial policy of lumping biosimilars that reference the same biologic under a single same billing code is not a high priority for the Trump administration, two sources in touch with the White House said Tuesday (June 13).

Thursday, 15 June 2017

Academics and policy experts said that value-based contracts, real-world evidence and drug repurposing for off-patent and on-patent drugs could help to spur competition and lower drug prices.

Tuesday, 13 June 2017

Senate Democrats on Tuesday (June 13) used a bipartisan hearing on drug prices to attack Republicans for not holding hearings on their emerging bill to cut billions of dollars in federal Medicaid funding and repeal chunks of the Affordable Care Act.

Tuesday, 13 June 2017

Senate health committee Chair Lamar Alexander (R-TN) plans to hold a second drug-pricing hearing in July that will examine how the drug development and approval process affects the cost of prescription drugs.

Monday, 12 June 2017

NEW YORK --The Supreme Court’s decision to punt on whether the so-called biosimilar patent dance is mandatory in the highly-watched Amgen v. Sandoz case leaves the state of play filled with “uncertainty and gamesmanship,” but companies are still likely to follow the patent dance process, an attorney who represents innovator biologic companies said Monday (July 12).

Monday, 12 June 2017

CMS, FDA and the Health Resources and Services Administration are developing recommendations for lowering drug prices, HHS Secretary Tom Price said Thursday (June 8), and providers worry the Part B drug price demonstration proposal might still be on the table, despite that the Obama administration deserted the idea in the face of opposition from drug makers, patients and cancer doctors.

Monday, 12 June 2017

The U.S. Supreme Court on Monday (June 12) issued a biosimilar-friendly ruling in the high-profile Amgen v Sandoz case involving key policies surrounding the biosimilar pathway, but one justice opined that FDA potentially could still depart from the court's interpretation as it gains more experience with the law.

Friday, 09 June 2017

A new analysis from Matrix Global Advisors finds that 74 drugs with total sales of $22.7 billion are subject to either an FDA-mandated Risk Evaluation and Mitigation Strategies (REMS) program with restricted distribution, or a self-imposed restricted distribution system.

Friday, 09 June 2017

House Energy & Commerce Committee Democrats formally requested in a letter Friday (June 9) that Chairman Greg Walden (R-OR) hold multiple hearings addressing high prescription drug costs.

Wednesday, 07 June 2017

The House Energy & Commerce Committee sent its user fee package to the floor, 54-0, Wednesday (June 7), tacking on several new amendments that deal with medical imaging, device servicing, accessory classification, a medical device safety pilot program and a sense of Congress urging the HHS secretary to take administrative actions to lower drug costs.

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