NIH Issues Clinical Trial Transparency Proposal; Expands Submissions to Results From Unapproved Products, Requires Detailed Adverse Event Information
Yesterday, the Department of Health and Human Services and the National Institutes of Health (NIH) proposed to “increase the transparency of clinical trials via information submitted to ClinicalTrials.gov.” NIH notes that “[a] major proposed change from current requirements is the expansion of the scope of clinical trials required to submit summary results to include trials of unapproved, unlicensed, and uncleared products.”
NIH also proposed a policy that would extend the similar registration and reporting requirements to all clinical trials funded by NIH, including phase 1 trials of drugs...
Source: Policy and Medicine - November 20, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs
FDA Solicits Comments on Best Practices for Communication Between the Agency and IND Sponsors
At the end of October, the U.S. Food and Drug Administration (FDA) announced it is seeking feedback to improve communication with the agency during the clinical trials process. The announcement, posted on the Federal Register, notes the agency opened a docket to allow for comments from interested parties such as regulated industry and academic institutions on practices for communication between FDA and investigational new drug application (IND) sponsors during drug development. From these comments, FDA hopes to identify and establish best practices to be included in the new draft guidance. Ideally, improved communication w...
Source: Policy and Medicine - November 17, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs
Addressing The Threat Of Antibiotic Resistance: Policy Solutions To Fix A Broken Pipeline
Recently, the White House released a major new national strategy to combat antibiotic resistance. As efforts begin to translate that unprecedented announcement into action, it is critical that any strategy to address resistance contain a plan to ensure an adequate antibiotic development pipeline. The overall number of antibiotics reaching the market has declined over time, with 29 and 23 new antibiotics approved in the U.S. in the 1980s and 1990s, respectively, but only nine between 2000 and 2010.
Meanwhile, the evolution of drug-resistance has outpaced the development of new antibiotics. Doctors routinely encounter patien...
Source: Health Affairs Blog - November 6, 2014 Category: Health Management Authors: Rachel Zetts and Allan Coukell Tags: All Categories Pharma Policy Public Health Research Source Type: blogs
Study Suggests that Telling Smokers the Truth About Electronic Cigarettes Could Enhance Smoking Cessation
Last week, I discussed a study, just published online ahead of print in the journal Nicotine & Tobacco Research, which reports the results of a population-based survey of smokers followed up after two years to determine whether e-cigarette use was associated with higher or lower rates of smoking cessation. The study found that intensive electronic cigarettes users at baseline were six times more likely to quit smoking after a two-year follow-up period compared to intermittent or non-users.One additional important finding of this study deserves mention.The study found a difference in the reasons for starting...
Source: The Rest of the Story: Tobacco News Analysis and Commentary - October 27, 2014 Category: Addiction Source Type: blogs
Drug Shortages Update
Conclusion
The Brief concludes by noting economists have predicted over time, manufacturer-reported investments in facilities and increased generic drug approvals may result in a market-driven correction, reducing shortages that exist today. Additionally, in the meantime, although both major parties agree on the threat posed from drug shortages, there is not agreement on major policy steps to further address the problem. Some authorities granted to FDA may help the situation, but ultimately both private and public sector actions are necessary. We will continue to follow the drug shortage issue and the need for consumers an...
Source: Policy and Medicine - October 23, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs
GDUFA Update: FDA Seeks Public Comment on Its Guidance Documents
On September 17, FDA hosted a public hearing on the Generic Drug User Fee Amendments of 2012 to solicit public comments on its guidances related to implementation of GDUFA.
GDUFA requires industry to pay user fees to supplement the costs of reviewing generic drug applications and inspecting facilities. In exchange, GDUFA ideally allows FDA to use those fees on resources to expedite the review process and speed access to safe and effective generic drugs for the public while also reducing costs to industry.
FDA designed GDUFA “to build on the success of the Prescription Drug User Fee Act (PDUFA),” which created a "...
Source: Policy and Medicine - October 3, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs
Biosimilars Update: FDA Releases “Purple Book”; Two Companies File Biosimilar Applications, Industry Responds to Draft Guidance
Vaccines, allergy shots, blood components, and gene therapies are examples of biological products. Most biologics are produced in living organisms, such as plant or animal cells, whereas small molecule drugs (most pharmaceuticals) are typically manufactured through chemical synthesis. The inherently complex nature of biologics makes them expensive to develop and impossible to copy in the manner traditionally associated with the approval of generic drugs.
BioSIMILAR, not BioEQUIVALENT
Enter “biosimilars,” which the Food and Drug Administration (FDA) defines as biological products that are highly similar to an already ap...
Source: Policy and Medicine - September 15, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs
The Role Of Black Box Warnings In Safe Prescribing Practices
TweetNote: In addition to Lara Maggs, Aaron Kesselheim also coauthored this post.
In the Health Affairs article, “Era of Faster Drug Approval Has Also Seen Increased Black-Box Warnings and Market Withdrawals,” published in the August issue, Cassie Frank and coauthors compare the number of approved prescription drugs that received black-box warnings or were withdrawn from the market for safety-related reasons prior to the 1992 Prescription Drug User Fee Act (PDUFA) with black-box warnings and safety-related withdrawals in the post-PDUFA era.
PDUFA for the first time authorized FDA to collect user fees from brand-name...
Source: Health Affairs Blog - August 20, 2014 Category: Health Management Authors: Lara Maggs and Aaron Kesselheim Tags: All Categories Bioethics Patient Safety Pharma Policy Public Health Source Type: blogs
FDA ANDA Submissions Content and Format of Abbreviated New Drug Applications
Recently, the US Food and Drug Administration (FDA) released a new draft guidance document on the content and format of generic drug submissions using the common technical document (CTD).
As reported, FDA's new draft guidance document, ANDA Submissions — Content and Format of Abbreviated New Drug Applications, is meant to help industry increase the quality of its submissions, the agency said in a Federal Register notice. The agency's hope is that by helping industry to increase submission quality, it can help it to meet the agency's obligations under the Generic Drug User Fee Act (GDUFA), which r...
Source: Policy and Medicine - August 18, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs
Antitrust Lawsuit Against Celgene Over Thalomid and Revlimid Focuses on REMS Requirements
Celgene's successful cancer drugs Thalomid and Revlimid are at the center of an antitrust action. On April 3rd, Mylan Pharmaceuticals Inc. filed an antitrust lawsuit against Celgene Corporation in the U.S. District Court of New Jersey, accusing Celgene of blocking generic competition from Thalomid and Revlimid. Mylan accused Celgene of abusing their FDA Risk Evaluation and Mitigation Strategy requirements in order to monopolize the cancer drug market.
As a background, in 2007, the Food and Drug Administration Amendments Act (FDAAA) gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from man...
Source: Policy and Medicine - August 14, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs
FDA Draft Guidance: Providing Submissions in Electronic Format--Postmarketing Safety Reports
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Providing Submissions in Electronic Format--Postmarketing Safety Reports." This draft guidance provides general information pertaining to electronic submission of postmarketing safety reports (individual case safety reports (ICSRs), attachments to ICSRs (ICSR attachments), and other postmarketing safety reports) for certain human drug and biological products. FDA is issuing the draft guidance to help persons required to submit postmarketing safety reports comply with the final rule.
Although you can comment on ...
Source: Policy and Medicine - June 24, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs
FDA Draft Guidance Analgesic Indications: Developing Drug and Biological Products
The FDA recently released a new draft guidance with recommendations on how sponsors of analgesic painkillers should develop products in preparation for future marketing authorization. The draft, "Analgesic Indications: Developing Drug and Biological Products", is intended for sponsors of analgesic products intended to treat acute, chronic and breakthrough pain.
All three types of pain—acute, chronic and breakthrough—are characterized by the need for long-term, regular treatment with analgesics. FDA notes that while it is important to understand how a single dose of the drug works, it's even more interested in underst...
Source: Policy and Medicine - February 27, 2014 Category: Health Medicine and Bioethics Commentators Authors: Thomas Sullivan Source Type: blogs
FDA: Policies and Procedures for Proposed Trial Design Aimed at Multiple Chronic Conditions
In a recent staff memo, Dr. Robert Temple, Deputy Director for Clinical Science at the FDA's Center for Drug Evaluation and Research (CDER) laid out a new policy in the Manual of Policies and Procedures (MAPP) that FDA staff should follow in reviewing proposed trial designs. This is part of the Department of Health and Human Services' Initiative on Multiple Chronic Conditions. In his memo, Dr. Temple stressed the FDA's interest in encouraging a broad population sample in the development of new drugs.
He writes: "This is reflected in the required (by regulation) analyses of safety and effectiveness by demographic and othe...
Source: Policy and Medicine - February 21, 2014 Category: Health Medicine and Bioethics Commentators Authors: Thomas Sullivan Source Type: blogs
FDA Once Again Rejects New Indication For Rivaroxaban
The third time wasn’t the charm. The FDA today turned turned down– for the third time– the supplemental New Drug Application (sNDA) for rivaroxaban (Xarelto, Johnson & Johnson) for use in acute coronary syndrome patients to reduce MI, stroke or death. In addition, the FDA– for the second time– turned down the sNDA for rivaroxaban in the same population for the reduction of stent thrombosis. Click here to read the full post on Forbes. (Source: CardioBrief)
Source: CardioBrief - February 14, 2014 Category: Cardiology Authors: Larry Husten Tags: MI/ACS People, Places & Events Policy & Ethics anticoagulation FDA Johnson & Johnson rivaroxaban stroke Source Type: blogs
FDA Panel Once Again Rejects New Indication For Rivaroxaban
The FDA’s Cardiovascular and Renal Drugs Advisory Committee once again turned down the supplemental new drug application for an acute coronary syndrome indication for Johnson & Johnson’s Xarelto (rivaroxaban). The nearly unanimous vote (10-0, with 1 abstention) was in line with a highly negative review from FDA staff members. … Click here to read the full post on Forbes. (Photo credit: Wikipedia) (Source: CardioBrief)
Source: CardioBrief - January 16, 2014 Category: Cardiology Authors: Larry Husten Tags: MI/ACS People, Places & Events Policy & Ethics FDA FDA advisory panel rivaroxaban Xarelto Source Type: blogs
