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December 2017

Vol. 34
No. 12


Full Issue of Generic Line in PDF Format

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Gottlieb to Delayers of Generics: ‘End the Shenanigans’

FDA Commissioner Scott Gottlieb once again chastised brand-name companies that slow-walk federal procedures and use regulations to delay the entry of generic competitors. Read More

Gottlieb Previews Upcoming Guidances on Complex Generics

The FDA is working to develop and finalize a handful of new guidances on bringing complex generics to market — including complicated medicines that may require alternate methods of establishing bioequivalence, as well as drug-device combination products that may be blocked by iterative patents. Read More

Supreme Court Divided on Future of the PTAB

The Supreme Court appeared divided on the constitutionality of the PTO’s patent re-examination process of inter partes review. Read More

First Month of GDUFA II Sees Large Spike in Generic CRLs

In the first month of the GDUFA II program, the FDA sent 325 complete response letters to generics manufacturers — far more than the high of 190 seen in August the fiscal year before. Read More

FDA Looks to Boost Industry Competition Through Deregulation

The FDA is using President Trump’s mandate to shrink the size of the government’s regulatory footprint as an opportunity to re-examine how its rules may be misused to delay generic competition — and to clear the decks of older regulations that advances in science have made obsolete, a senior HHS official told lawmakers. Read More

UK Watchdog Claims Concordia Overcharged for Thyroid Generic

The UK’s competition watchdog agency claimed the drugmaker Concordia overcharged the NHS by millions for its hypothyroid medication liothyronine, also known as Cytomel, following price increases of almost 6,000 percent over a decade. Read More

FDA Updates Generics Comms Guidance for GDUFA II

The FDA updated its guidance on communications with generics manufacturers to reflect the timelines agreed to in the second generation of the GDUFA program, which took effect Oct. 1. Read More

FDA Outlines Guidance for Generic Abuse-Deterrent Opioid Pills

The FDA finalized guidance for manufacturers looking to produce generic versions of opioid painkillers with abuse-deterrent labeling, as a part of the agency’s push to lower overall exposure to opioids and prevent new addictions. Read More

PTAB Issues New Rule Governing Attorney-Client Privilege

The PTO’s Patent Trial and Appeal Board issued a final rule clarifying when attorney-client privilege is recognized during the inter partes review process — as well as which communications are protected when seeking patents at the PTO or at foreign intellectual property offices. Read More

FDA Outlines BsUFA II Fee Structure in Draft Guidance

The FDA published a draft guidance explaining the new biosimilar fee structure under BsUFA II and the types of fees that took effect Oct. 1. The draft also covers how to submit payments to the agency, the consequences for failing to pay and how to request reconsiderations of fee assessments. Read More

FDA Updates Priority ANDA Pre-submission Guidance

Responding to changes introduced by the GDUFA II program, the FDA revised its draft guidance on sponsor pre-submissions of facility information used to assess the need for manufacturing site inspections for priority applications. Read More

Tufts: Biologics Makers Need More Adaptable Strategies

Makers of biopharmaceuticals will need to become more modular and agile to adjust for trends in personalized medicine and oncology, according to the Tufts Center for the Study of Drug Development. Read More

PhRMA, AAM Spar on Hatch-Waxman Provisions

The Hatch-Waxman amendments did not strike a good balance between generic access and brand-name innovation, according to public comments to the FDA from both PhRMA and the Association for Accessible Medicines — however the two groups disagree as to how. Read More

FDA Expands ANDA Prioritization Policy

Under a new category of generic ANDAs eligible for priority review, the FDA will prioritize applications likely to be ready for approval shortly after the six months of marketing exclusivity that is awarded to a first-to-file generic drug. Read More

FDA Takes Aim at Delaying Tactics for Shared REMS

The FDA is working to prevent manufacturers of branded high-risk drugs from stalling an application for approval of a generic competitor via manipulation of a requirement to share safety programs, Commissioner Scott Gottlieb said. Read More

FTC: Number of Pay-for Delay Settlements Continues to Drop

The number of “pay-for-delay” patent settlements agreed to by pharmaceutical companies in fiscal 2015 declined from the year before, according to a report from the Federal Trade Commission. Read More

States Widen Generics Price-Fixing Lawsuit, Name Names

A multistate price-fixing lawsuit against generic drugmakers should be dramatically expanded to target more drugs, more companies and, for the first time, individual company executives, the attorneys general who filed the litigation told a federal court. Read More

J&J Sued for Blocking Biosimilar Remicade Competition

A workers’ benefits fund filed a lawsuit claiming Johnson & Johnson maintained an illegal monopoly for its blockbuster drug Remicade, employing anticompetitive schemes involving insurer contracts, rebate protocols and bundling. Read More