Life Science Compliance Update

April 18, 2018

Gottlieb Discusses Opioids and Lays Out Vision

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On Wednesday, April 4, 2018, Food and Drug Administration (FDA) Commissioner Scott Gottlieb spoke at the National Rx Drug Abuse and Heroin Summit. Gottlieb opened by comparing recent opioid deaths to those that happened at the peak of the AIDS epidemic in 1995. He started off discussing different strategies the FDA has pursued to address the challenges presented by the current crisis, especially those that help reduce overall exposure to opioids and preserve access for the patients who need them.

He mentioned that often, the opioid addiction “starts with a prescriber’s pen, either directly or indirectly,” meaning either they are prescribed the drugs directly or they receive leftover, stolen, or otherwise acquired drugs, of family and friends. He noted there is a lack of evidence-based guidelines to inform clinical practice for opioid use, and this is hampering prescribers from providing personalized pain management and addiction treatment at the point of care.

Throughout his speech, Gottlieb highlighted four main areas for improvement to address the opioid epidemic: supporting education and training, developing evidenced based guidelines, enhancing enforcement, and advancing electronic prescribing systems and policies.

Supporting Education and Training

Commissioner Gottlieb did acknowledge the revised FDA Blueprint and the way its regulatory authority was extended, but also stated that FDA’s REMS is optional for prescribers. He went so far as to suggest that it may be time to consider making it mandatory, “given the scale of the epidemic.” One potential approach that he suggested would be to require the training of the prescribers at the time they register with the DEA and again at registration renewal.

Commissioner Gottlieb continued, noting, “This training could also include information about the appropriate dose and duration of opioid analgesic use for the most common outpatient indications. To reinforce this training, this information could be made easily available at the point of care so practitioners could incorporate more of it into their prescribing decisions.”

Evidence-Based Prescribing

He also expressed a desire to collaborate with professional societies to develop evidence-based guidelines on the appropriate dose and duration for some common procedures. He suggested that this new data and evidence would not be relied upon for primary evidence of effectiveness, but instead, on how providers can better use the drugs when there are significant safety concerns present about abuse.

He also stated, that the Agency and the public need to seek better information that we could more easily incorporate into the labels of opioid alternatives; like when an NSAID and acetaminophen combination is a suitable, if not better alternative to an immediate release opioid. He also mentioned a proposal the FDA is pursuing to streamline the monograph process that currently governs Over-the counter (OTC) labeling could allow this kind of information to be more easily incorporated into the labels of common OTC pain relievers.

E-Prescribing

Gottlieb offered support for improving prescribing platforms that make it easier for doctors to adopt evidence-based guidelines. He believes a “robust e-prescribing system could streamline access for patients with chronic pain who are appropriately managed on an opioid therapy as the history of safe-use could be documented in the system, allowing greater ease for both patients and their providers,” which would allow clinicians and pharmacists to focus their attention on new opioid prescriptions instead of appropriately-managed patients who suffer from chronic pain. 

Commissioner Gottlieb further mentioned his support for Congress’ efforts to pass legislation that would create a uniform system of electronic prescriptions for controlled substances and integration of Electronic Health Records (HER) and Prescription Drug Monitoring Program (PDMP), as well as data sharing across PDMPs.

Enforcement

Gottlieb also called on social media companies, internet service providers and others to collaborate with the FDA to stop illegal efforts to distribute opioids in their tracks. According to Gottlieb, FDA will host a summit meeting with CEOs and other senior representatives of the internet stakeholders, academics, and advocacy groups to identify technology gaps and new solutions.

He referenced a report by the U.S. Senate Permanent Subcommittee on Investigations, which found that online sellers offered to sell fentanyl and ship any purchases through the “international arm of the U.S. Postal Service,” and accepted a variety of payment options, including Bitcoin. The sellers would even offer “flash sales” on their products to entice buyers. The investigators used payment information to identify more than 500 financial transactions totaling $230,000 linked to 300 individuals in 43 states. 

In a hearing on January 25, Senator Rob Portman, the Subcommittee Chair, said that their investigation found that: “…online sellers were quick to respond, unafraid of getting caught, and ready to make a deal. They offered discounts for bulk purchases and even tried to up-sell us to carfentanil – a powerful synthetic opioid that is so strong it’s used as an elephant tranquilizer. Ordering these drugs was as easy as buying any other product online.”   

FDA has investigators conducting some dark web operations, resulting in some notable take-downs. He is asking for the help of internet firms to help the FDA continue to crack down on these violations.

Conclusion

Commissioner Gottlieb ended his speech by recognizing that “we haven’t seen meaningful, voluntary actions,” when it comes to opioids and to that end, the FDA is planning to host a summit with CEOs and other senior representatives of internet stakeholders, academics, and various advocacy groups to identify technology gaps and possible solutions.

Both the House and the Senate are working on a variety of bipartisan proposals that could be included in the next legislative package addressing the opioid epidemic. The House Energy and Commerce Committee has the third in its hearing series on this topic scheduled for April 11th, during which the Committee will consider more than two dozen bipartisan bills. The Senate Finance committee and the Senate HELP committee are both involved in finding a resolution as well and are still working on solidifying hearing dates.

April 13, 2018

OPDP Sends First Untitled Letter of 2018

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Here we are…barely finished with the first quarter of 2018, and the United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) has finally issued its first untitled letter of the year. The letter, sent to Collegium Pharmaceutical, dealt with an exhibit promoting the company’s opioid drug Xtampza ER (oxycodone).

The exhibit in question was Collegium’s exhibit booth at the American Society of Health-System Pharmacists’ summer 2017 meeting. The exhibit promoted Xtampza ER, which is an opioid approved for managing "pain severe enough to require daily, around-the-clock, long-term opioid treatment" and is limited for use in patients who have exhausted other treatment options such as non-opioid analgesics and immediate-release opioids. The drug is also approved for abuse-deterrent label claims for being resistant to manipulation by cutting, crushing, grinding, chewing and dissolving.

According to the FDA’s letter, "the exhibit booth makes false or misleading representations because it fails to adequately communicate information about the serious risks associated with Xtampza ER use." FDA notes that an OPDP official saw the exhibit in person at the event and that the side panel "utilized a much smaller font size and plain white background, without any visual elements linking it to the principal display panel."

Specifically, the “exhibit booth presentation included a principal display panel that prominently presented benefit claims about the abuse-deterrent properties of Xtampza ER, but failed to include any information with respect to the drug’s limitations of use, which state that due to the risks of addiction, abuse, misuse, overdose and death, Xtampza ER should only be used in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Nor did the principal display panel include any information with respect to the indication or serious and life-threatening risks such as those contained in the product’s BOXED WARNING.”

Further, while some of the benefit claims regarding Xtampza ER’s abuse-deterrent properties were prominently presented at eye level and easy to read, material information from the regarding the limitation of such properties in preventing abuse was almost hidden, presented at the bottom of the panel near the floor.

FDA also notes that the issues present in the exhibit are similar to ones FDA addressed in feedback to Collegium in 2016, where OPDP recommended that Collegium revise proposed presentations so that they did not misrepresent the approved indication or omit important context; misrepresent or omit important risk information; or omit other material information.

"In particular, we cautioned Collegium about failing to present risk information for Xtampza ER with a prominence and readability reasonably comparable to the presentation of benefits. We are concerned that Colleguim is promoting Xtampza ER in a manner that fails to address the very serious risks of the drug, despite this direction from OPDP," FDA writes.

OPDP has requested that Collegium stop violating the FDC Act and submit a written  response to the letter stating its intent to comply with the request, listing any and all promotional items for the drug with the statements outlined in the letter, and what the plan is for discontinuing the violative promotions.

We will have a more in-depth review of this letter, and what it may mean for industry overall, in an upcoming issue of Life Science Compliance Update.

April 06, 2018

Gottlieb Discusses Opioids and Lays Out Vision - Google it's Your Turn

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On Wednesday, April 4, 2018, Food and Drug Administration (FDA) Commissioner Scott Gottlieb spoke at the National Rx Drug Abuse and Heroin Summit. Gottlieb opened by comparing recent opioid deaths to those that happened at the peak of the AIDS epidemic in 1995. He started off discussing different strategies the FDA has pursued to address the challenges presented by the current crisis, especially those that help reduce overall exposure to opioids and preserve access for the patients who need them.

He mentioned that often, the opioid addiction “starts with a prescriber’s pen, either directly or indirectly,” meaning either they are prescribed the drugs directly or they receive leftover, stolen, or otherwise acquired drugs, of family and friends. He noted there is a lack of evidence-based guidelines to inform clinical practice for opioid use, and this is hampering prescribers from providing personalized pain management and addiction treatment at the point of care.

Throughout his speech, Gottlieb highlighted four main areas for improvement to address the opioid epidemic: supporting education and training, developing evidenced based guidelines, enhancing enforcement, and advancing electronic prescribing systems and policies.

Supporting Education and Training

Commissioner Gottlieb did acknowledge the revised FDA Blueprint and the way its regulatory authority was extended, but also stated that FDA’s REMS is optional for prescribers. He went so far as to suggest that it may be time to consider making it mandatory, “given the scale of the epidemic.” One potential approach that he suggested would be to require the training of the prescribers at the time they register with the DEA and again at registration renewal.

Commissioner Gottlieb continued, noting, “This training could also include information about the appropriate dose and duration of opioid analgesic use for the most common outpatient indications. To reinforce this training, this information could be made easily available at the point of care so practitioners could incorporate more of it into their prescribing decisions.”

Evidence-Based Prescribing

He also expressed a desire to collaborate with professional societies to develop evidence-based guidelines on the appropriate dose and duration for some common procedures. He suggested that this new data and evidence would not be relied upon for primary evidence of effectiveness, but instead, on how providers can better use the drugs when there are significant safety concerns present about abuse.

He also stated, that the Agency and the public need to seek better information that we could more easily incorporate into the labels of opioid alternatives; like when an NSAID and acetaminophen combination is a suitable, if not better alternative to an immediate release opioid. He also mentioned a proposal the FDA is pursuing to streamline the monograph process that currently governs Over-the counter (OTC) labeling could allow this kind of information to be more easily incorporated into the labels of common OTC pain relievers.

E-Prescribing

Gottlieb offered support for improving prescribing platforms that make it easier for doctors to adopt evidence-based guidelines. He believes a “robust e-prescribing system could streamline access for patients with chronic pain who are appropriately managed on an opioid therapy as the history of safe-use could be documented in the system, allowing greater ease for both patients and their providers,” which would allow clinicians and pharmacists to focus their attention on new opioid prescriptions instead of appropriately-managed patients who suffer from chronic pain. 

Commissioner Gottlieb further mentioned his support for Congress’ efforts to pass legislation that would create a uniform system of electronic prescriptions for controlled substances and integration of Electronic Health Records (HER) and Prescription Drug Monitoring Program (PDMP), as well as data sharing across PDMPs.

Enforcement

Gottlieb also called on social media companies, internet service providers and others to collaborate with the FDA to stop illegal efforts to distribute opioids in their tracks. According to Gottlieb, FDA will host a summit meeting with CEOs and other senior representatives of the internet stakeholders, academics, and advocacy groups to identify technology gaps and new solutions.

He referenced a report by the U.S. Senate Permanent Subcommittee on Investigations, which found that online sellers offered to sell fentanyl and ship any purchases through the “international arm of the U.S. Postal Service,” and accepted a variety of payment options, including Bitcoin. The sellers would even offer “flash sales” on their products to entice buyers. The investigators used payment information to identify more than 500 financial transactions totaling $230,000 linked to 300 individuals in 43 states. 

In a hearing on January 25, Senator Rob Portman, the Subcommittee Chair, said that their investigation found that: “…online sellers were quick to respond, unafraid of getting caught, and ready to make a deal. They offered discounts for bulk purchases and even tried to up-sell us to carfentanil – a powerful synthetic opioid that is so strong it’s used as an elephant tranquilizer. Ordering these drugs was as easy as buying any other product online.”   

FDA has investigators conducting some dark web operations, resulting in some notable take-downs. He is asking for the help of internet firms to help the FDA continue to crack down on these violations.

Conclusion

Commissioner Gottlieb ended his speech by recognizing that “we haven’t seen meaningful, voluntary actions,” when it comes to opioids and to that end, the FDA is planning to host a summit with CEOs and other senior representatives of internet stakeholders, academics, and various advocacy groups to identify technology gaps and possible solutions.

Both the House and the Senate are working on a variety of bipartisan proposals that could be included in the next legislative package addressing the opioid epidemic. The House Energy and Commerce Committee has the third in its hearing series on this topic scheduled for April 11th, during which the Committee will consider more than two dozen bipartisan bills. The Senate Finance committee and the Senate HELP committee are both involved in finding a resolution as well and are still working on solidifying hearing dates.

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