On Monday, the Rules Committee of the House of Representatives will adopt a provision that would expand the ability of the US Department of Defense to urgently approve medical products, according to the US Food and Drug Administration Commissioner. United (FDA) Scott Gottlieb for the provision to be rejected
According to the committee conference report on the National Defense Authorization Act for fiscal year 2018, the House will add the Senate amendment to authorize the Secretary of Defense to approve the emergency use of medical products outside of the US. UU., Expanding the capacity of the Department of Defense to approve these products.
"Participants agree that the traditional routes for the approval and authorization of the Food and Drug Administration of critical medical products for the care of combat victims are too slow to allow a rapid insertion and use of these products on the battlefield "said the report.
Speakers in the House noted "even higher survival rates due to severe combat injuries and injuries suffered by service members" as a reason to add the provision, although they said they expect the FDA to be consulted when evaluating medical products for the care of combat victims and use this new authority strictly for the approval of medical products for injuries and injuries on the battlefield. "
The FDA and the Department of Defense are already working together on the emergency use authorizations (EUA), including the DoD presentations, in accordance with the FDA's guidance on the use of said US as of January. For example, in 2014, the FDA issued an EUA to authorize the use of the EZ1 Real-Time DZ-PCR Assay of the Department of Defense for the detection of Ebola Zaire virus during the outbreak in West Africa.
The decision to add the provision to the House bill followed Gottlieb's comments earlier this week, which is rare for an agency that often says it will not comment on pending legislation, which must maintain such approvals within the scope of the FDA. The former commissioners of the FDA have also had problems with the provision.
And the move to carry it out in the House committee on Monday may not indicate that the change is final. Senator Patty Murray (D-WA) told Axios that an agreement had been reached with Senator Lamar Alexander (R-TN) to maintain US reviews under the FDA, but the DoD could pressure the FDA to expedite certain product reviews.
Monday, November 13, 2017
Thursday, November 2, 2017
Pay-for-Delay Deals: FTC Notes Continued Decline Since SCOTUS Ruling
The total number of transactions in which brand-name drug companies pay to delay the entry of generic competitors continues to decline, and only 5 of 170 final 2015 settlements included generic compensation and entry restriction generic, the Federal Trade Commission (FTC) said in a report released on Wednesday.
Fiscal 2015 is the second full year of filings since the Supreme Court ruled FTC v. Canada. Actavis, Inc. in June 2013, when it concluded that a drug company's transfer to a generic competitor to settle a patent dispute could violate antitrust laws. The decline in fiscal 2015 follows a similar decline revealed in a report from the FTC last year.
"In accordance with the 2014 fiscal year, the number of settlements that can lead to late payment continues to decline significantly as a result of the Actavis decision, even though the total number of settlements filed with the FTC has increased," the report says.
During the 2015 financial year, the total number of definitive settlements was 170, compared to 140 in 2012, 145 in 2013 and 160 in 2014. However, the number of potential deferred payment agreements fell to 14 in 2015, from a high of 40 late payment settlements for fiscal year 2012.
Of these 14, 10 included compensation in the form of a cash payment only for litigation costs (one of which included a cash payment of more than $ 7 million), while the other four included a promise of non-commercialization. an authorized generic in competition with the generic manufacturer for a period.
Ten additional definitive regulations are classified by the FTC as containing "possible compensation" because it is not clear whether certain provisions in the agreements are equivalent to what should be considered compensation for the generic patent applicant.
"For example, an agreement containing a declining royalty structure, in which the generic's obligation to pay royalties is reduced or eliminated if a brand launches an authorized generic product, can have the same effect as an explicit commitment without MGAs. ", says the report. .
In addition, 126 of the 170 final regulations limited the ability of the generic manufacturer to market its product, but did not include explicit or possible compensation ...
Fiscal 2015 is the second full year of filings since the Supreme Court ruled FTC v. Canada. Actavis, Inc. in June 2013, when it concluded that a drug company's transfer to a generic competitor to settle a patent dispute could violate antitrust laws. The decline in fiscal 2015 follows a similar decline revealed in a report from the FTC last year.
"In accordance with the 2014 fiscal year, the number of settlements that can lead to late payment continues to decline significantly as a result of the Actavis decision, even though the total number of settlements filed with the FTC has increased," the report says.
During the 2015 financial year, the total number of definitive settlements was 170, compared to 140 in 2012, 145 in 2013 and 160 in 2014. However, the number of potential deferred payment agreements fell to 14 in 2015, from a high of 40 late payment settlements for fiscal year 2012.
Of these 14, 10 included compensation in the form of a cash payment only for litigation costs (one of which included a cash payment of more than $ 7 million), while the other four included a promise of non-commercialization. an authorized generic in competition with the generic manufacturer for a period.
Ten additional definitive regulations are classified by the FTC as containing "possible compensation" because it is not clear whether certain provisions in the agreements are equivalent to what should be considered compensation for the generic patent applicant.
"For example, an agreement containing a declining royalty structure, in which the generic's obligation to pay royalties is reduced or eliminated if a brand launches an authorized generic product, can have the same effect as an explicit commitment without MGAs. ", says the report. .
In addition, 126 of the 170 final regulations limited the ability of the generic manufacturer to market its product, but did not include explicit or possible compensation ...
Tuesday, October 24, 2017
UK Strategy for Pharmacopeial Quality Standards for Biologics: MHRA Discusses Comments
According to a report published Monday, trade associations, manufacturers, universities and researchers gave their opinion on the draft strategy of the UK Medicines and Health Products Regulatory Agency (MHRA) for standards development. pharmacological.
In general, the MHRA argues that the value of standardization has been confirmed and that standards could add value, including providing guidance and ensuring consistency of product characterization and quality control, ensuring the performance of standards. analytical methods and facilitate the development of bioanalytical methods.
context
In January, the MHRA asked for comment on its strategy as more organic products entered the market and the regulator sought to become "a precursor and precursor of innovative approaches to standardizing biological drugs."
MHRA has established a five-year strategy for biological pharmacological standards, with a first step in comparing its current approach to the development of biological monographs with alternative procedures. The regulator is also planning to identify gaps and weaknesses in its current portfolio of standards and strengthen its understanding of these needs, including strengthening industry linkages and knowledge of how manufacturers control quality. products.
These and other activities will require the MHRA and its regulatory units, the National Institute of Biological Standards and Control and the British Pharmacopoeia, to pool their resources.
Earlier this year, a group of government agencies was established to help implement the strategy, including experts from the MHRA, UK Innovation Office, British Pharmacopoeia and NIBSC.
Consultation Comments
MHRA says: "It was clear that many stakeholders felt that both the type and function of" standards "were essential to ensure they were fit for purpose."
For example, for biotechnologically produced proteins, comments indicated that standards "should not be unnecessarily restrictive and allow the development of new products and technologies over time", while recognizing the specific nature of these concepts standardization products.
For Advanced Therapy Medicine (ATMP), commentators stated, "Due to the emerging nature and complexity of this product category, it is important that the standards developed are not unnecessarily restrictive and do not impede key areas in which standards could add value would be the development of a common understanding and the coherence of testing methodologies. "
The MHRA also noted that for ATMPs, "there was a strong preference for non-mandatory guidance, including standards for specific analytical technologies and techniques supported, as appropriate, by physical standards.
A number of interest groups also suggested exploring two new concepts for complex biological drugs, such as monoclonal antibodies, although MHRA notes that they were previously recommended in an International Federation of Pharmaceutical Manufacturers' Associations (IFPMA) and the European Generics Association (EGA) 2014.
Setting the standards for raw materials has also been "widely recommended," MHRA said. "Control of raw materials was considered important because its properties could influence the critical quality attributes of bulk biological substances."
Looking ahead, the MHRA reports that it will hold a symposium in 2018 on the progress of its work on pharmacopoeia standards and that annual updates will be provided through symposia or online events.
In general, the MHRA argues that the value of standardization has been confirmed and that standards could add value, including providing guidance and ensuring consistency of product characterization and quality control, ensuring the performance of standards. analytical methods and facilitate the development of bioanalytical methods.
context
In January, the MHRA asked for comment on its strategy as more organic products entered the market and the regulator sought to become "a precursor and precursor of innovative approaches to standardizing biological drugs."
MHRA has established a five-year strategy for biological pharmacological standards, with a first step in comparing its current approach to the development of biological monographs with alternative procedures. The regulator is also planning to identify gaps and weaknesses in its current portfolio of standards and strengthen its understanding of these needs, including strengthening industry linkages and knowledge of how manufacturers control quality. products.
These and other activities will require the MHRA and its regulatory units, the National Institute of Biological Standards and Control and the British Pharmacopoeia, to pool their resources.
Earlier this year, a group of government agencies was established to help implement the strategy, including experts from the MHRA, UK Innovation Office, British Pharmacopoeia and NIBSC.
Consultation Comments
MHRA says: "It was clear that many stakeholders felt that both the type and function of" standards "were essential to ensure they were fit for purpose."
For example, for biotechnologically produced proteins, comments indicated that standards "should not be unnecessarily restrictive and allow the development of new products and technologies over time", while recognizing the specific nature of these concepts standardization products.
For Advanced Therapy Medicine (ATMP), commentators stated, "Due to the emerging nature and complexity of this product category, it is important that the standards developed are not unnecessarily restrictive and do not impede key areas in which standards could add value would be the development of a common understanding and the coherence of testing methodologies. "
The MHRA also noted that for ATMPs, "there was a strong preference for non-mandatory guidance, including standards for specific analytical technologies and techniques supported, as appropriate, by physical standards.
A number of interest groups also suggested exploring two new concepts for complex biological drugs, such as monoclonal antibodies, although MHRA notes that they were previously recommended in an International Federation of Pharmaceutical Manufacturers' Associations (IFPMA) and the European Generics Association (EGA) 2014.
Setting the standards for raw materials has also been "widely recommended," MHRA said. "Control of raw materials was considered important because its properties could influence the critical quality attributes of bulk biological substances."
Looking ahead, the MHRA reports that it will hold a symposium in 2018 on the progress of its work on pharmacopoeia standards and that annual updates will be provided through symposia or online events.
Tuesday, October 10, 2017
EMA Adds New Excipients to Labeling Requirements
The European Medicines Agency (EMA) updated on Monday its annex to the European Commission guidelines on the labeling of excipients, adding five new excipients and extending the safety warnings required for 10 others.
Excipients are defined as any part of a drug other than the active pharmaceutical ingredient. Most excipients are considered inactive, although some may cause reactions under certain circumstances. For example, lactose is commonly used as a filler in tablets, but may cause reactions in patients lactose intolerant.
This document lists excipients known to have a recognized action or effect and is to be declared on the label and package leaflet, is being updated for the first time since its publication in 2003.
The update also comes at a time when the European Commission is considering revising its guidelines on the labeling of excipients following a public consultation that ended in May.
The five newly listed excipients include boric acid, cyclodextrins, phosphate buffers, sodium laurilsulfate and perfumes containing allergens. The appendix includes an appendix listing 26 specific perfume allergens such as cinnamon and oak moss that must be included in the labeling.
Regarding new safety information, the EMA indicates that the revised Annex "pays particular attention to ... the safety of these excipients when used in children or pregnant women". For example, the appendix contains new safety information that should be included in the package leaflet for benzyl alcohol-containing medicines that advise pregnant or lactating women to consult with their doctor or pharmacist before taking the drug.
The EMA indicates that the revised Annex enters into force immediately for all centrally and nationally authorized medicinal products and that current marketing authorization holders are required to update the labeling of their products at the first opportunity. For products that are not subject to regulation, the EMA indicates that developers are required to submit a Type IB variant detailing labeling changes over the next three years
Excipients are defined as any part of a drug other than the active pharmaceutical ingredient. Most excipients are considered inactive, although some may cause reactions under certain circumstances. For example, lactose is commonly used as a filler in tablets, but may cause reactions in patients lactose intolerant.
This document lists excipients known to have a recognized action or effect and is to be declared on the label and package leaflet, is being updated for the first time since its publication in 2003.
The update also comes at a time when the European Commission is considering revising its guidelines on the labeling of excipients following a public consultation that ended in May.
The five newly listed excipients include boric acid, cyclodextrins, phosphate buffers, sodium laurilsulfate and perfumes containing allergens. The appendix includes an appendix listing 26 specific perfume allergens such as cinnamon and oak moss that must be included in the labeling.
Regarding new safety information, the EMA indicates that the revised Annex "pays particular attention to ... the safety of these excipients when used in children or pregnant women". For example, the appendix contains new safety information that should be included in the package leaflet for benzyl alcohol-containing medicines that advise pregnant or lactating women to consult with their doctor or pharmacist before taking the drug.
The EMA indicates that the revised Annex enters into force immediately for all centrally and nationally authorized medicinal products and that current marketing authorization holders are required to update the labeling of their products at the first opportunity. For products that are not subject to regulation, the EMA indicates that developers are required to submit a Type IB variant detailing labeling changes over the next three years
Sunday, October 1, 2017
ICH Plans Work on Clinical Trials Guideline Revision, Pediatric Extrapolation
The International Council of Harmonization (CIE) is considering two new issues, according to the report published Thursday at the group's Montreal meeting in May and June.
Both topics include the first review of ICH's 1997 General Clinical Trial Guidelines and a new directive on pediatric extrapolation in clinical trials proposed by the US Food and Drug Administration (FDA).
The ICH Assembly also adopted brainstorming tables for both topics and the FDA proposed to lead informal working groups to finalize concept papers and develop business plans to move forward with the guidelines.
During the meeting, the ICH Assembly also voted to approve the China Food and Drug Administration (CFDA) as a regulatory member and the Cooperation System for Pharmaceutical Inspection (PIC / S) as an observer of the group.
Progress in other guidelines
The minutes also detail the updates submitted to the ICH Assembly on other guidelines at different stages of development or review.
For the ongoing review of its Guidelines on Carcinogenicity Studies of Rodents, ICH S1 (R1), the Rapporteur of the Working Group of Experts informed the meeting that 40 carcinogenicity assessment documents have been compiled and summary reports of the regulatory authorities and the document is expected to reach Step 2a / b in June or November 2018.
The EWG of the forthcoming directive on non-clinical safety trials for pediatric medicines (S11) also indicated that it expects to finalize a Phase 1 document before the ICH meeting in Geneva, November, in November.
ICH guideline E17 on multiregional clinical trials is also expected to reach Stage 3 at the Geneva meeting and to reach Stage 4 at the meeting based on the result of a 5 6 days to review the comments in the guide.
Regarding the technical and regulatory considerations of ICH, P12 for the management of the life cycle of pharmaceuticals, the Assembly noted that the Phase 1 document should be subject to a legal review for the EU, here in the middle September 2017 before members can decide to approve the document for Step 2.
The informal working group of Guideline E19 for the optimization of safety data collection also reported that the guideline is expected to reach the first step in November 2018.
During the meeting, the ICH Assembly also approved work plans for the E2B Directive (R3) on the electronic submission of individual case safety reports, the M2 Directive on electronic standards for transfer, the M9 Directive on biopharmaceutical based products in the biopharmaceutical classification system and the M10 Directive on the validation of the bioanalytical method. It is also expected that the M9 and M10 Guidelines will reach Stage 1 in June 2018.
Both topics include the first review of ICH's 1997 General Clinical Trial Guidelines and a new directive on pediatric extrapolation in clinical trials proposed by the US Food and Drug Administration (FDA).
The ICH Assembly also adopted brainstorming tables for both topics and the FDA proposed to lead informal working groups to finalize concept papers and develop business plans to move forward with the guidelines.
During the meeting, the ICH Assembly also voted to approve the China Food and Drug Administration (CFDA) as a regulatory member and the Cooperation System for Pharmaceutical Inspection (PIC / S) as an observer of the group.
Progress in other guidelines
The minutes also detail the updates submitted to the ICH Assembly on other guidelines at different stages of development or review.
For the ongoing review of its Guidelines on Carcinogenicity Studies of Rodents, ICH S1 (R1), the Rapporteur of the Working Group of Experts informed the meeting that 40 carcinogenicity assessment documents have been compiled and summary reports of the regulatory authorities and the document is expected to reach Step 2a / b in June or November 2018.
The EWG of the forthcoming directive on non-clinical safety trials for pediatric medicines (S11) also indicated that it expects to finalize a Phase 1 document before the ICH meeting in Geneva, November, in November.
ICH guideline E17 on multiregional clinical trials is also expected to reach Stage 3 at the Geneva meeting and to reach Stage 4 at the meeting based on the result of a 5 6 days to review the comments in the guide.
Regarding the technical and regulatory considerations of ICH, P12 for the management of the life cycle of pharmaceuticals, the Assembly noted that the Phase 1 document should be subject to a legal review for the EU, here in the middle September 2017 before members can decide to approve the document for Step 2.
The informal working group of Guideline E19 for the optimization of safety data collection also reported that the guideline is expected to reach the first step in November 2018.
During the meeting, the ICH Assembly also approved work plans for the E2B Directive (R3) on the electronic submission of individual case safety reports, the M2 Directive on electronic standards for transfer, the M9 Directive on biopharmaceutical based products in the biopharmaceutical classification system and the M10 Directive on the validation of the bioanalytical method. It is also expected that the M9 and M10 Guidelines will reach Stage 1 in June 2018.
Sunday, September 10, 2017
Expedited Approval Pathways Associated With Increased Safety-Related Label Changes, Study Finds
In their 15-year data analysis, authors Sana Mostaghim, Joshua Gagne and Aaron Kesselheim of the Regulatory, Therapeutic and Legal (PORTAL) Program at Brigham and Women's Hospital and Harvard Medical School found that the fastest drug approvals had a higher percentage of tag changes related to safety than those approved for non-accelerated routes.
"More research is needed to understand the underlying factors of the process that contribute to the differential rates in the safety changes that were observed in this analysis," the authors added. "Policymakers are likely to need to ensure that these channels are not overused, that there is sufficient oversight of post-approval compliance approved by these channels, and that patients and clinicians are fully exposed to the risks associated with the widespread use of accelerated development and channels of regulatory review in the approval of new drugs. "
With the implementation of 21st Century Curative legislation, more treatments are expected to receive rapid approvals, especially regenerative medications.
The authors point out that increasing safety tag changes underscore the importance of accelerated follow-up of approved drugs "to help identify emerging problems that require a change in the safety tag as soon as possible," write the authors.
And while drugs that accelerate approval usually include a statement about "clinical benefit ... not established" because of "dependence on an incomplete validated measure," the authors suggest that there must also be formal requirements for manufacturers warn patients about the higher rate of subsequent changes in the safety labeling of drugs approved by channels of accelerated adoption, fast path or priority.
The authors also point out several limitations to their research, including that the rate of safety changes "does not provide a qualitative assessment of the clinical relevance of a particular change.
"For example, adding the" risk of serious cardiovascular events "to the boxed warning of a label in which already had cardiovascular outcomes mentioned could have less clinical impact than the addition of new psychiatric secondary effects that were not included in this section the label, "they write. "Such a qualitative analysis of label changes is complicated by the fact that in some cases the FDA only indicates that a change has been made, but it presents the whole section of the label and in others it emphasizes or italicizes the text but does not indicates what has been changed The FDA's clarity about the exact nature of each label change and the number of changes each month would be helpful in resolving these issues.
Thursday, August 31, 2017
IPRF and IGDRP to Consolidate Regulatory Initiatives in 2018
The International Forum of Pharmaceutical Regulators (IPRF) and the International Program for the Regulation of Generic Drugs (IGDRP) have agreed to consolidate their work in a joint initiative to be operational in January 2018.
According to a summary of the 5th IGDRP meeting in Ottawa in June, the IPRF Management Committee and the IGPRR Steering Committee expressed their support for consolidating the IPRF and IGPRR initiatives to better address the issues Complex and challenges faced by regulatory authorities and organizations.
The consolidation of these two regulatory collaborations should allow for a shared vision for information exchange and regulatory cooperation, maximize synergies and avoid duplication efforts, create a regulatory center for pharmaceutical products that covers all Allowing for closer links with initiatives to simplify the many forms of international regulatory collaboration and improve governance for management committees and technical working groups.
The Consolidated Management Committee intends to hold its first face-to-face meeting in June 2018.
"Given the imminent consolidation of the IPRF with IGDRP, a revised joint strategic vision will be developed for the consolidated entity in the near future," said IPRF.
In addition, the International Council for Harmonization (ICH) Assembly approved a proposal by the IPRF Management Committee that the ICH Secretariat provide support services to the IPRF as of 1 January 2018.
"The Secretariat's support services will cover the needs of the future consolidated entity IPRF and IGDRP," the group added.
The next meeting of the IPRF Management Committee will be held on 12 and 13 November 2017 in Geneva, Switzerland.
According to a summary of the 5th IGDRP meeting in Ottawa in June, the IPRF Management Committee and the IGPRR Steering Committee expressed their support for consolidating the IPRF and IGPRR initiatives to better address the issues Complex and challenges faced by regulatory authorities and organizations.
The consolidation of these two regulatory collaborations should allow for a shared vision for information exchange and regulatory cooperation, maximize synergies and avoid duplication efforts, create a regulatory center for pharmaceutical products that covers all Allowing for closer links with initiatives to simplify the many forms of international regulatory collaboration and improve governance for management committees and technical working groups.
The Consolidated Management Committee intends to hold its first face-to-face meeting in June 2018.
"Given the imminent consolidation of the IPRF with IGDRP, a revised joint strategic vision will be developed for the consolidated entity in the near future," said IPRF.
In addition, the International Council for Harmonization (ICH) Assembly approved a proposal by the IPRF Management Committee that the ICH Secretariat provide support services to the IPRF as of 1 January 2018.
"The Secretariat's support services will cover the needs of the future consolidated entity IPRF and IGDRP," the group added.
The next meeting of the IPRF Management Committee will be held on 12 and 13 November 2017 in Geneva, Switzerland.
Subscribe to:
Posts (Atom)