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Drug Pricing

September 04, 2014 | Daily News

The chain drug store lobby wants CMS to institute a number of changes leading up to 2015 open enrollment to ensure that consumers seeking prescription drug coverage starting next year do not experience disruptions. In a letter to CMS Administrator Marilyn Tavenner, the National Association of Chain Drug Stores asks that CMS allow pharmacists to use “one-time overrides” of claims denials in January for difficult cases, consider having call centers remain open on holidays, and ensure that qualified health plans send beneficiary files on a timely basis.

September 02, 2014 | Daily News

Par Sterile Products last week sued Hospira and Finnish drug maker Orion Corporation raising antitrust issues related to FDA's approval of generic versions of the sedative drug Precedex, which also has been challenged in a separate lawsuit that has stalled market entry. Par alleges that Hospira staked out a monopoly in part by “manipulating” an FDA process to document drug patents.

August 29, 2014 | Daily News

Drug companies are pressing FDA to explain what its new "similar" category of biosimilars, which falls below the statutory "highly similar" measure, means for products that meet the lower bar, reacting to three new categories unveiled in FDA's draft biosimilar guidance on clinical pharmacology. The guidance's suggestion that immunogenicity data could be collected postmarket also has sparked confusion, with originator biologic makers urging FDA to require such data be gathered before biosimilars hit the market.

August 28, 2014 | Daily News

A federal District Court judge Wednesday (Aug. 27) rejected PhRMA's request that it throw out the Health Resources and Services Administration's new interpretive rule on 340B orphan drug exclusions, which is substantively identical to a rule the court vacated in May, but said the drug industry is free to file another lawsuit on the new rule.

August 27, 2014 | Daily News

An emerging court battle over the generic drug Precedex, if successful, could arm branded drug companies with a way to block generic drug competition by preventing label carve outs with Orange Book patent listings, industry attorneys said. Hospira sued FDA last week after the agency approved generic versions of the company's sedation drug Precedex with labeling that carved out a patent-protected use; Hospira contends that the product's two uses overlap and the product is still under patent protection.

August 27, 2014 | Daily News

The United Compounding Network, which was launched last month to negotiate with payers and pharmacy benefit managers on reimbursement for compounded drugs, named its key leaders, including a former high-level manager from Express Scripts, a PBM which has drawn the ire of compounders for recently restricting its coverage of such products.

August 26, 2014 | Daily News

The global generic drug trade lobby may pull out of the International Conference of Harmonisation unless it gets a seat on ICH's standards-setting steering committee, which issues quality guidelines that affect biosimilar and generic drug companies, the lobby group warns in an Aug. 8 letter to ICH. The International Generic Pharmaceutical Alliance is upset that ICH in a recent meeting decided to shut the generic drug industry out the steering committee, which includes regulators and brand-name drug industry officials from major industrialized countries around the world.

August 25, 2014 | Daily News

As the August congressional recess draws to a close, a slew of House lawmakers within and beyond the Energy and Commerce Committee are drawing ideas from local constituents and key officials about medical innovation that could be included in discussions for the House 21st Century Cures Initiative. Rep.

August 25, 2014 | Daily News

As August recess draws to a close, a slew of House lawmakers within and beyond the Energy and Commerce Committee are drawing ideas from local constituents and key officials about medical innovation that could be included in discussions for the House 21st Century Cures Initiative. Rep.

August 19, 2014 | Daily News

Just as the country is on the verge of a significant increase in drug spending, brand-drug makers are lobbying for a trade deal that could severely constrain the ability of Medicare to curb drug prices, consumer groups warn.

August 18, 2014 | Daily News

A coalition of specialist physicians recently asked FDA to assign distinguishable names to biosimilar, saying National Drug Codes would not be a sufficient way for physicians to to track problems with these products. The physicians said many prescribers believe that shared nonproprietary names indicate the drugs are approved for the same indications, which might not always be the case for biosimilars, and any findings of interchangeabilty could become “moot” if all biosimilars share names with the reference product.

August 15, 2014 | Daily News

FDA will hold a public meeting next month on new Generic Drug User Fee Act policies that some fear could neglect applications submitted during the first two years of the program while the agency takes on new review metrics for other submissions throughout the remainder of GDUFA

August 14, 2014 | Daily News

The Generic Pharmaceutical Association -- about a week before the World Health Organization formally unveiled a biosimilar naming proposal -- met with FDA to lay out its position, saying any change to the current system must apply to all biologics and retroactively, according to slides from the meeting. GPhA officials, lobbyists and several member company representatives met July 24 with Sally Howard, deputy commissioner for policy, planning and legislation, according to FDA records.

August 14, 2014 | Daily News

A key biosimilar developer, Hospira, supports the World Health Organization's biologic naming approach -- a qualifier attached to the nonproprietary name -- but with some big caveats, including that it should not be used for prescribing. Innovator drug makers support WHO's biological qualifier idea, according to recently released minutes from an April WHO meeting where stakeholders staked out positions on the idea before it was formally unveiled last month.

August 13, 2014 | Daily News

The health law's reductions in disproportionate share hospital payments may increase the importance of 340B drug discounts for some safety-net providers, but key policies surrounding the discount program remain in flux as the administration works internally to resolve issues that have long pit drug makers against safety-net hospitals, RAND Corporation says in an issue brief.

August 13, 2014 | Daily News

Former PhRMA President and House Energy & Commerce Committee Chair Billy Tauzin says Congress should create a separate path for curative drugs that spans research and development, FDA review and reimbursement. Although FDA's breakthrough-drug program wasn't designed for cures, it could be a good starting point for the review portion of that unique path, the former Louisiana Republican lawmaker tells Inside Health Policy.

August 07, 2014 | Daily News

The World Health Organization's newly unveiled plan for biological qualifiers -- a naming solution that accounts for the emergence of biosimilars -- re-asserts the longstanding question of where FDA stands on the contentious issue of whether biosimilars should share names with their reference products. The issue is ripe for a decision: FDA is reviewing the first public biosimilar application and HHS faces pressure from lawmakers and stakeholders to unveil a naming policy.