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Topic: Opioids
Product: Opioids
Company: Various
Petition Filer: Columbia University
Petition Number(s): 2009P-0227
Date of Petition: May 29, 2009
Responding Petitions:Issue and Implication: Whether the physician and patient information accompanying opioid products is sufficient to ensure patient safety and prevent abuse.
Action Requested by Petitioner: The petitioner requests that all opioid products be required to undergo a Risk Evaluation and Mitigations Strategies (REMS) analysis. In addition to developing such a strategy for each product, petitioner further requests that additional communications and training around safe opioid use be employed.
Summary of Petition(s): Petitioner notes that opioid products are important medications for pain management. However, these are ripe for abuse and addiction. While some products have such REMS protocols, petitioner asks to see these taken class-wide for all opioids.
FDA Action: FDA issued an interim response November 18, 2009. On June 25, 2013, FDA denied this petition.
Product: Opioids
Company: Various
Petition Filer: Tufts Health Care Institute
Petition Number(s): 2009P-0252
Date of Petition: June 10, 2009
Responding Petitions:Issue and Implication: Whether additional measures can be taken to enhance patient safety and prevent abuse of opioids.
Action Requested by Petitioner: Similar to the above, Petitioner is requesting additional standards and measures for opioid products.
Summary of Petition(s): Petitioner makes several requests to help reduce abuse of opioids such as fast-tracking non-dependent pain management products.
FDA Action: FDA issued an interim response November 25, 2009. On April 7, 2015, FDA issued its Action. While it “granted and denied” the petition, it in effect denied the substance of the petition. It granted the requests that FDA was already doing to mitigate the abuse potential and encourage deterrence formulations but denied the remaining requests of the petition.
Product: Opiods
Company: Various
Petition Filer: Physicians for Responsible Opioid Prescribing
Petition Number(s): 2012P-0818
Date of Petition: July 30, 2012
Responding Petitions:Issue and Implication: Whether current labels for opioid products are sufficient to ensure safe use.
Action Requested by Petitioner: The Petitioner would like to have FDA modify all opioid labels for non-cancer patients in three respects. First, the products should be indicated for severe pain. Second, the daily dosage should have a maximum limit equivalent to 100mg of morphine. Third, there should be a duration restriction of 90 days continuous use.
Summary of Petition(s): Petitioner is a group of physicians who treat patients for pain management. Today, opioids are over-prescribed and subject to abuse and addiction. Citing many studies regarding the over-prescribing and mismanagement of opioids, this group of physicians believes that changing the label will help reduce the problem.
As you can imagine, many consumers commented on this petition. These comments will not be reproduced here.
FDA Action: On September 10, 2013, FDA granted/denied this petition.
Product: Opioids
Company: Various
Petition Filer: Center for Lawful Access and Abuse Deterrence
Petition Number(s): 2013P-0703
Date of Petition: June 19, 2013
Responding Petitions:Issue and Implication: Whether additional measures can be taken to enhance patient safety and prevent abuse of opioids.
Action Requested by Petitioner: Similar to all of the above, Petitioner is requesting additional standards and measures for opioid products.
Summary of Petition(s): Petitioner makes several requests to help reduce abuse of opioids such as requiring all new opioids (NDA or ANDA) to establish that their products increase abuse deterrence and also to have greater access to Medication-Assistance Treatment (MAT) to help people gain independence from opioid addiction.
FDA Action: On October 24, 2013, FDA granted and denied this petition, noting that it is already working on draft guidance of abuse deterrence and treatment.
Product: Opioids
Company: Various
Petition Filer: National Advocates for Pregnant Women
Petition Number(s): 2013P-1288 and 2013P-1289
Date of Petition: November 18, 2013
Responding Petitions:Issue and Implication: Whether FDA can properly implement proposed label changes.
Action Requested by Petitioner: The Petitioner is asking FDA to refrain from implementing label changes to opioid products regarding uses and warnings in pregnant women.
Summary of Petition(s): Petitioner filed these two similar petitions which also refers to 2012P-0818 (above). Apparently, FDA is moving forward with certain label changes that Petitioner does not care for. Petitioner argues that the changes will yield additional safety issues and are not in the “interest of justice.”
Petitions like these will undoubtedly cause many patients to comment which comments will not be followed here.
FDA Action: On April 16, 2014, FDA denied both of these petitions.
Citizen Petition (2013P-1288)
FDA Action (2013P-1288)
Citizen Petition (2013P-1289)
FDA Action (2013P-1289)Product: Opioids
Company: Various
Petition Filer: Purdue Pharma
Petition Number(s): 2014P-0205
Date of Petition: February 25, 2014
Responding Petitions:Issue and Implication: Whether class labeling on extended-release products must also be applied to immediate release products.
Action Requested by Petitioner: The Petitioner is asking FDA to apply the same safety labeling changes that were imposed on long-acting and extended-release opioid analgesics to immediate release formulations.
Summary of Petition(s): Petitioner makes several opioids including OxyContin®(oxycodone), MS Contin®(morphine), Butrans®(buprenorphine), and Dilaudid®(hydromorphone). In response to the safety issues and adverse events associated with these and other opioids, FDA issued class labeling changes on September 10, 2013 to promote safe use and abuse/misuse deterrence of these extended-release and long-acting products. However, as Petitioner points out, these labeling changes do not apply to immediate release opioids even though many contain the same active ingredients as the extended-release products and which are the root cause of the safety issues addressed by the new labeling.
In the labeling changes, FDA noted that the new changes would not be applied to immediate release products because, as the FDA states, the risks are “disproportionate” for the extended release products when compared to immediate release. However, Petitioner disagrees and makes the simple argument that the adverse consequences of immediate release products are reasonably even with those of extended release products meriting similar safety labeling. Furthermore, it would create a lot less confusion for prescribers and patients if the labeling were similar.
Petitioner submitted a supplement on July 24, 2015. The Supplement attaches a letter and request from Congress to require certain labeling from immediate release products and generally supports the Petitioner’s request.
This petition also attracted a few comments from consumers which will not be reproduced here.
FDA Action: ON March 22, 2016, FDA issued its action. While it did require some new labeling, it substantively denied this petition.
Citizen Petition
Supplement
FDA ActionProduct: Opioids
Company: Various
Petition Filer: Pharmaceutical Manufacturing Research Services
Petition Number(s): 2016P-0645
Date of Petition: February 26, 2016
Responding Petitions: See 2017P-3064 belowIssue and Implication: Whether current rules regarding labeling are sufficient to deter abuse of certain formulations.
Action Requested by Petitioner: The Petitioner would like the FDA to establish new criteria for permitting the label to include “abuse deterrent” including pre-marketing proof of manipulation and extraction studies for both small and large volume extractions; post-marketing field proof that the product is abuse deterrent; and subject any currently marketed “abuse deterrent” formulations to undergo these proof requirements.
Summary of Petition(s): Petitioner notes the dangers of opioids and the likelihood of abuse of these products along with the health dangers and risks these pose. While FDA has addressed these concerns, Petitioner believes that these are still inadequate. For example, in approving the reformulated OxyContin, FDA required “liking” studies, but the “abuse deterrent” formulation is still subject to abuse and misuse and the outcomes of adverse events and death. Petitioner argues that the FDA Guidance is not sufficient as proven by the outcome of the abuse deterrent OxyContin. It therefore requests stronger scientific proof pre- and post-marketing to ensure true abuse deterrence of formulations.
On August 29, 2016, Petitioner filed a supplement.
FDA Action: On December 20, 2018, FDA denied this petition.
Citizen Petition
Supplement
FDA Action©2016 Parry Ashford Inc
Product: Opioids
Company: Various
Petition Filer: City of Baltimore
Petition Number(s): 2016P-0689
Date of Petition: February 26, 2016
Responding Petitions:Issue and Implication: Whether opioid and benzodiazepine labeling is sufficient to ensure safe use.
Action Requested by Petitioner: The Petitioner is requesting that all opioid and benzodiazepine products carry a box warning that concomitant use of these class of products can increase the risk of fatal overdoses.
Summary of Petition(s): Petitioner first comments on the dangers of opioid use and abuse. Then it presents great amounts of data regarding the increased risks of adverse events and fatalities when opioid and benzodiazepine products are used together in both clinical and abuse settings. For example, the number of hospital admissions from this use has increased dramatically over the past ten years, and in Maryland, about 1 in 5 deaths from opioid use also include benzodiazepine use. The studies and data demonstrate the increase risk which merits boxed warnings on both classes of drugs.
FDA Action: On August 31, 2016, FDA substantively granted the petition, adding boxed warning.
Product: Opioids
Company: Various
Petition Filer: Pharmaceutical Manufacturing Research Services
Petition Number(s): 2017P-1359
Date of Petition: March 7, 2017
Responding Petitions: See 2017P-3064 belowIssue and Implication: Whether current rules regarding labeling are sufficient to deter abuse of certain formulations.
Action Requested by Petitioner: The Petitioner is essentially asking that OxyContin and other opioids be removed from the market in their extended-release form.
Summary of Petition(s): As a follow on to its prior petition (see above 2016P-0645), Petitioner is asking FDA to revoke the long-term indications from opioid products and further to revoke the approval of the latest formulation reiteration of OxyContin. Petitioner makes the argument that its abuse-deterrent formulation was not properly approved and that the risks of long-term use of any of these products greatly outweigh their marginal benefit.
FDA Action: Pending.
Product: Roxybond®(oxycodone) Tablets
Company: Inspirion
Petition Filer: Pharmaceutical Manufacturing Research Services
Petition Number(s): 2017P-3064
Date of Petition: May 16, 2017
Responding Petitions: Daiichi SankyoSummary of Petition(s): This petition is part new petition, part comment/supplement to petitions 2016P-0645 and 2017P-1359. It is asking FDA to not approve the NDA oxycodone Roxybond (NDA 209777) until the two-referenced petitions are resolved.
On September 7, 2017, Daiichi Sankyo, the developer of Roxybond submitted a response, asking FDA to deny the petition. It notes that this was the first approved immediate release, abuse-deterrent opioid under the new FDA framework and met all of the scientific rigor and scrutiny. The FDA Guidance of the abuse deterrence went through a significant commentary and rigorous process to ensure that the goals of abuse deterrence could be met. The Petition is simply flawed in its presentation of facts. The product went met many criteria for approval, and the Petition is seeking to argue over the standards FDA developed. The Petition itself is asking FDA to “undo” its Guidance processes which it cannot permit under the petition process.
FDA Action: On October 31, 2017, FDA denied this petition.
Citizen Petition
Daiichi Sankyo Comment
FDA ActionProduct: Opioids
Company: Various
Petition Filer: Center for Lawful Access and Abuse Deterrence
Petition Number(s): 2017P-4039
Date of Petition: July 3, 2017Summary of Petition(s): This petition asks FDA to require a transition from opioids and morphine products to ones that have abuse deterrent labeling. In other words, several of these products have abuse deterrent formulations while others do not. It is asking FDA to set a date that requires all of these products to be manufactured and labeled with abuse deterrent formulations.
FDA Action: Pending.
Product: Oxycodone Extended Release Tablets
Company: Intellipharmaceutics
Petition Filer: Pharmaceutical Manufacturing Research Services
Petition Number(s): 2017P-4352
Date of Petition: July 20, 2017
Responding Petitions:Summary of Petition(s): Here, Petitioner is asking FDA to refrain from approving the pending NDA 209653 from Intellipharmaceutics as it is asking for a chronic or long-term use which will lead to further addiction and add to the opioid crisis.
FDA Action: On December 15, 2017, FDA denied this petition.
Product: Opioids
Company: Various
Petition Filer: Dennis Ryll
Petition Number(s): 2017P-5370
Date of Petition: August 31, 2017
Responding Petitions:Summary of Petition(s): This petition is another in a long-line of them filed by citizens. This one asks for additional boxed warnings.
FDA Action: On November 28, 2018, Petitioner withdrew this petition.
Citizen Petition
Petition WithdrawalProduct: Opioids
Company: Various
Petition Filer: Physicians for Responsible Opioid Prescribing
Petition Number(s): 2017P-5396
Date of Petition: September 1, 2017
Responding Petitions:Summary of Petition(s): This petition asks that ultra high dose opioids be removed from the market.
FDA Action: Pending.
Product: Opioids
Company: Various
Petition Filer: Pharmaceutical Manufacturing Research Services
Petition Number(s): 2018P-4338
Date of Petition: November 15, 2018
Responding Petitions:Issue and Implication: Whether current rules regarding labeling are sufficient to deter abuse of certain formulations.
Action Requested by Petitioner: The petitioner is asking FDA to refrain from approving any opioid product that has an indication (or other mention) on its label for the use in chronic pain management. Specifically, it also asks FDA to refrain from approving NDA 209774 from SpecGx LLC for this same reason.
Summary of Petition(s): Petitioner restates the dangers associated with long-term and chronic use of opioids in terms of addiction and abuse. The SpecGx product is seeking approval for chronic pain management and others may be as well. Hence, it is asking FDA to not approve of these labels.
On August 29, 2016, Petitioner filed a supplement.
FDA Action: On April 12, 2019, FDA denied this petition.
Product: Opioids
Company: Various
Petition Filer: Public Citizen
Petition Number(s): 2019P-1364 and 2019P-1643
Date of Petition: March 21, 2019 and April 5, 2019
Responding Petitions:Summary of Petition(s): Public Citizen asks FDA to stop all approvals of pending applications of opioid products due to the well-known safety and addiction risks. Petitioner filed a second petition (2019P-1643) asking for the same thing but seemingly extending it to any reformulated and new opioids, asking for a moratorium on any approvals. On April 8, 2019, Petitioner withdrew the 2019P-1364 petition in favor of the 2019P-1643 petition. It also filed an amendment to this petition which was sealed. On April 11, 2019, Petitioner then withdrew the 2019P-1643 petition and promised to file a better one at a later date which it did on April 16, 2019 (2019P-1783). FDA denied 2019P-1783 on 9/6/19.
Citizen Petition (2019P-1364)
Petition Withdrawal (2019P-1364)
Citizen Petition (2019P-1643)
Petition Withdrawal (2019P-1643)
Citizen Petition (2019P-1783)
FDA Action (2019P-1783)Product: Opioids
Company: Various
Petition Filer: Dr. Francis O’Donnell
Petition Number(s): 2020P-1575
Date of Petition: June 17, 2020
Responding Petitions:Summary of Petition(s): In this petition, Dr. O’Donnell asks FDA to add a boxed warning to opioid products and further recommends a treatment protocol and titration process.
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Gregory Glass
FDA Petitions
