REMS from Elsevier Business Intelligence

PDUFA Cost Offset In House Focuses On FDA Petition Review, Not REMS

Mon, 28 May 2012 00:00:00 -0400

Faced with a CBO estimate that H.R. 5651 will increase federal spending in fiscal years 2013 through 2022, the House Energy and Commerce Committee applies a section that speeds FDA decisions on some petitions to biosimilars. This contrasts with the Senate bill, which allows FDA to require brand companies to sell products covered by limited distribution systems to generic firms.

Two Indications, One REMS: FDA Panel Debates Restricted Access For Truvada In PrEP

Mon, 21 May 2012 00:00:00 -0400

FDA did not ask its Antiviral Drugs Advisory Committee whether Gilead’s proposed REMS for pre-exposure prophylaxis should include restricted distribution, but it still got an earful on the subject from some vocal panel members, who said prescribing should be limited only to individuals with documentation of a negative HIV test. Agency staff, however, said such an approach was impractical due to Truvada’s unrestricted availability for HIV treatment.

Behavioral Considerations Abound In FDA Review Of Truvada For PrEP

Mon, 21 May 2012 00:00:00 -0400

The potential dangers associated with medication non-adherence, failure to obtain regular HIV testing and “risk compensation” were cited by critics as reasons not to approve Truvada for pre-exposure prophylaxis. Although Gilead’s proposed REMS targets these behaviors, it remains to be seen whether such risk management efforts will have an impact.

Truvada PrEP REMS Needs More Work, FDA Panel Says

Mon, 14 May 2012 00:00:00 -0400

In a marathon meeting, the Antiviral Drugs Advisory Committee endorses use of Gilead’s emtricitabine/tenofovir fixed-dose combination for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV infection, but some committee members say Gilead’s REMS needs more “teeth,” including a linkage between a documented negative HIV test and access to the drug.

Truvada PrEP REMS Needs More Work, FDA Panel Says

Mon, 14 May 2012 00:00:00 -0400

Truvada PrEP REMS Needs More Work, FDA Panel Says

Fri, 11 May 2012 00:00:00 -0400

Truvada Pre-Exposure Prophylaxis Data Have FDA Looking Ahead To REMS

Tue, 08 May 2012 00:00:00 -0400

Seemingly comfortable with the clinical data supporting a PrEP indication for the emtricitabine/tenofovir combination, FDA will ask its Antiviral Drugs Advisory Committee for input on Gilead’s proposed REMS, which does not include prescribing restrictions. FDA will ask the May 10 panel to vote whether the risk/benefit profile is acceptable in various subgroups.

The Impact of REMS on Generic Drug Approvals and Drug Competition

Thu, 03 May 2012 00:00:00 -0400

From the conception of the REMS in the FDAAA Act of 2007, Congress was concerned that giving FDA authority to impose new post-marketing controls could raise competitive issues about market access for generics. Congress was right to be concerned.

Current Class Of Risk Evaluation & Mitigation Strategies

Tue, 01 May 2012 00:00:00 -0400

Here is a general outline of the REMS FDA has mandated so far, as well as a listing of drugs where it has been announced that REMS are being developed or drugs with safety issues that could invoke a REMS.

FDA Grades Itself Highly In Reports On Safety Of Imported Products And Marketed Drugs

Tue, 24 Apr 2012 00:00:00 -0400

As Congressional markups of user fee bills looms, the agency describes actions it has taken to protect the international supply chain in its Global Engagement report; another report notes the REMS and drug safety studies it has mandated under its postmarket drug safety program.

Post-Market Safety Updates Replaced By “Periodic Benefit-Risk Evaluation Reports”

Thu, 12 Apr 2012 00:00:00 -0400

Draft guidance from FDA would adopt the International Conference on Harmonization’s periodic benefit-risk evaluation reports, which will offer sponsors the opportunity to provide updates on benefit information along with safety signals to the regulatory authorities.

Post-Market Safety Updates Replaced By “Periodic Benefit-Risk Evaluation Reports”

Tue, 10 Apr 2012 00:00:00 -0400

Current Class Of Risk Evaluation & Mitigation Strategies

Sun, 01 Apr 2012 00:00:00 -0400

Establishing an Effective REMS Process: Significant Implications of Risk Management

Mon, 19 Mar 2012 00:00:00 -0400

Today – from request through acceptance – the REMS process remains a daunting one. And its multidisciplinary scope demands constant cross-company synchronization – from Phase I studies through clinical development, to regulatory review, approval, and commercialization.Whether you’re an industry veteran or a relative newcomer, understanding REMS is both a challenge and a requirement, which is why this two-day workshop should be requisite learning for all pharmaceutical professionals.

“Adaptive Licensing” Proposals View REMS As Answer To Limited Evidence

Mon, 12 Mar 2012 00:00:00 -0400

Some ideas for new drug approval pathways seem to envision the use of Risk Evaluation and Mitigation Strategies as a means for preventing and monitoring off-label use following initial approval, apparently without regard to the seriousness or extent of a product’s risks. Given the burdens currently created by REMS, any effort to expand and retrofit the programs to a new approval pathway is likely to draw pushback from the health care community.

Current Class Of Risk Evaluation & Mitigation Strategies

Thu, 01 Mar 2012 00:00:00 -0500

Setting the Stage: Qnexa and the Power of REMS

Thu, 01 Mar 2012 00:00:00 -0500

Vivus’ second trip to an advisory panel was a much happier one, with the company’s weight loss therapy garnering an overwhelming “yes” vote on approvability. The key change?

Workshop: Establishing an Effective REMS Process: Significant Implications of Risk Management

Mon, 27 Feb 2012 00:00:00 -0500

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Qnexa REMS Should Deter Off-Label Use Of Components, But Not Place Undue Burden

Mon, 27 Feb 2012 00:00:00 -0500

The Endocrinologic and Metabolic Drugs Advisory Committee voted 20-2 in favor of approving the combination of phentermine and topiramate for weight loss during its second review of Vivus’ application.

Workshop: Establishing an Effective REMS Process: Significant Implications of Risk Management

Mon, 20 Feb 2012 00:00:00 -0500

"The Pink Sheet" Subscribers -- Save an Extra 20% Off Register Today! Transforming the field of pharmaceutical risk management, the Food and Drug Administration Amendments Act of 2007 (FDAAA) granted the U.S.

Corcept’s Voluntary Central Distribution Helps Korlym Evade REMS

Fri, 17 Feb 2012 00:00:00 -0500

FDA required no REMS, though Korlym (mifepristone), also known as RU-486, will carry a boxed warning that the therapy for Cushing’s syndrome will terminate pregnancy; Corcept has set up distribution through a central pharmacy.

Establishing an Effective REMS Process: Significant Implications of Risk Management

Mon, 13 Feb 2012 00:00:00 -0500

Special Early Bird Savings Thru 2/15! See the Registration section below.Transforming the field of pharmaceutical risk management, the Food and Drug Administration Amendments Act of 2007 (FDAAA) granted the U.S.

Current Class Of Risk Evaluation & Mitigation Strategies

Wed, 01 Feb 2012 00:00:00 -0500

REMS Need Metrics For Assessing Success, Burden On Health Care System

Mon, 30 Jan 2012 00:00:00 -0500

“We don’t really have clear methods for assessing burden and access,” CDER’s Mary Willy acknowledges. A lack of baseline information hinders the measurement of whether REMS and their components are working.

CMS Expands Meaning Of “Retail Community Pharmacy” In AMP Rule

Mon, 30 Jan 2012 00:00:00 -0500

CMS’ proposed rule on the average manufacturer price for drugs includes specialty and home infusion pharmacies in the law’s definition of “retail community pharmacy” for the purpose of calculating AMP, citing drugs subject to Risk Evaluation and Mitigation Strategies from FDA as the reason.

Alexza’s Revised Adasuve REMS Borrows From Risk Management Plan For Zyprexa Relprevv

Wed, 25 Jan 2012 00:00:00 -0500

A resubmitted Risk Evaluation and Mitigation Strategy that proposes to limit use of inhaled loxapine to health care facilities with ready access to advanced airway support borrows from language in the REMS for Lilly’s long-acting intramuscular injection formulation of olanzapine, Alexza’s CEO says.

Alexza’s Revised Adasuve REMS Borrows From Risk Management Plan For Zyprexa Relprevv

Mon, 23 Jan 2012 00:00:00 -0500

Current Class Of Risk Evaluation & Mitigation Strategies

Sun, 01 Jan 2012 00:00:00 -0500

Shared REMS For Transmucosal Fentanyls Could Expand Market For Meda’s Onsolis As It Exits More Restrictive Program

Sun, 01 Jan 2012 00:00:00 -0500

Class-wide Risk Evaluation and Mitigation Strategy for transmucosal immediate-release fentanyl products will begin operations in March 2012, with participants in REMS for individual products to be transitioned automatically to the new system.

Shared REMS For Transmucosal Fentanyls Could Expand Market For Meda’s Onsolis As It Exits More Restrictive Program

Thu, 29 Dec 2011 00:00:00 -0500

Multaq REMS May Be Revamped As Label Adds New Risks

Wed, 21 Dec 2011 00:00:00 -0500

After several years of regulatory struggles Sanofi’s anti-arrhythmic Multaq finally got to market. But results from a new study have drawn attention to safety problems in higher-risk patients and could damage the drug’s commercial opportunity.

Multaq REMS May Be Revamped As Label Adds New Risks

Mon, 19 Dec 2011 00:00:00 -0500

Adasuve’s Extensive REMS Proposal Raises Questions About Whether It Could Work In Practice

Mon, 19 Dec 2011 00:00:00 -0500

Patient screening to ensure pulmonary risks are mitigated could be difficult in emergency room settings, advisory committee says about inhaled loxapine formulation.

FDA Standardizing REMS Re-Enrollment Procedures

Tue, 06 Dec 2011 00:00:00 -0500

Common registration site for participants in REMS was endorsed by several panel members during a joint meeting of the Drug Safety and Risk Management and Dermatologic and Ophthalmic Drugs Advisory Committees.

FDA Standardizing REMS Re-Enrollment Procedures

Fri, 02 Dec 2011 00:00:00 -0500

Current Class Of Risk Evaluation & Mitigation Strategies

Thu, 01 Dec 2011 00:00:00 -0500

Amgen Hopes That Downgrading Nplate REMS Can Escape NCD

Wed, 30 Nov 2011 00:00:00 -0500

If FDA is potentially willing to downgrade the risk management plan for the immune thrombocytopenia treatment Nplate (romiplostim), CMS should drop the drug from consideration for a National Coverage Determination, the company argues.

REMS Refinement: Does iPLEDGE’s Evolution Have Lessons For Opioids?

Tue, 29 Nov 2011 00:00:00 -0500

The Drug Safety and Risk Management and Dermatologic and Ophthalmic Drugs Advisory Committees will assess the risk management program Dec. 1 for lessons about implementing REMS containing elements to assure safe use and selecting assessment metrics.

Final Guidance Clarifies Distribution Requirements For MedGuides

Mon, 21 Nov 2011 00:00:00 -0500

Final policy on distribution of Medication Guides and inclusion in Risk Evaluation and Mitigation Strategies makes clear what FDA considers a material change.

Current Class Of Risk Evaluation & Mitigation Strategies

Tue, 01 Nov 2011 00:00:00 -0400

REMS Use Declining, But Post-Marketing Requirements Remain

Tue, 01 Nov 2011 00:00:00 -0400

Not surprisingly, FDA is imposing REMS less frequently in the fourth year of its new post-marketing authorities. But mandatory trial requirements appear to be rising, as is the use of the most burdensome type of REMS.

FDA Cmte. To Scrutinize Pulmonary Safety, REMS For Alexza's Inhaled Antipsychotic

Mon, 24 Oct 2011 00:00:00 -0400

FDA's Psychopharmacologic Drugs Advisory Committee will meet Dec. 12 to discuss efficacy and safety of Adasuve, an inhalable version of loxapine, for rapid treatment of agitation in schizophrenic and bipolar patients.

Tysabri Usage Restrictions Likely To Remain Stable As FDA Considers REMS Modifications

Thu, 20 Oct 2011 00:00:00 -0400

While the label of Biogen Idec/Elan's multiple sclerosis drug is expected to be changed to reflect a suspected link between JC-virus and the viral brain infection progressive multifocal leukoencephalopathy, that is unlikely to lead to a new contraindication.

Warning Letter On Adverse Event Reporting May Stem As Much From Jazz Reaction As REMS Problem

Tue, 18 Oct 2011 00:00:00 -0400

Jazz Pharmaceuticals initially admitted it had known about 10 deaths and 64 other serious, unexpected adverse drug experiences associated with its cataplexy drug Xyrem, but later changed its story, FDA says.

HHS OIG Reviewing REMS, SBIR Eligibility, Patient Safety Organizations

Mon, 17 Oct 2011 00:00:00 -0400

The HHS Office of Inspector General recently released its Work Plan for Fiscal Year 2012, which describes new and ongoing investigations. Below are investigations that pertain to FDA, the National Institutes of Health and the Agency for Healthcare Research and Quality.

iPLEDGE Again On FDA Advisory Agenda, This Time As An Example

Thu, 13 Oct 2011 00:00:00 -0400

"REMS-related topics" is the theme of a joint FDA advisory committee meeting Dec. 1 focused on the landmark iPLEDGE program as an example of the effect such programs have on the health care system.

Brand/Generic Battles Over REMS Raise Constitutional Questions For FDA

Mon, 10 Oct 2011 00:00:00 -0400

ANDA sponsors may increasingly face a new roadblock to FDA approval: a Risk Evaluation and Mitigation Strategy (REMS) that restricts access to samples of the brand name product.

Current Class Of Risk Evaluation & Mitigation Strategies

Sat, 01 Oct 2011 00:00:00 -0400

PDUFA Commitment Letter Formalizes REMS Standardization Schedule

Thu, 01 Sep 2011 00:00:00 -0400

Among other timetables set as part of the broad deal with industry, FDA will host meetings and issue guidances to assess and minimize the burden of REMS on the practitioners and patients.

Current Class Of Risk Evaluation & Mitigation Strategies

Thu, 01 Sep 2011 00:00:00 -0400