Industry News
MOUNT PROSPECT, IL — The National Association of Boards of Pharmacy® (NABP®) released a new RogueRx Activity Report, Injectable Weight Loss Drugs: How Illegal Online Drug Sellers Are Taking Advantage of Patients, which explores how bad actors are taking advantage of glucagon-like peptide-1 receptor agonist (GLP-1 agonist) medications "going viral." This class of drugs, including semaglutide, liraglutide, and tirzepatide, is used to treat type 2 diabetes and obesity. Among patients, these drugs are commonly known for promoting weight loss. Unfortunately, because of the drugs' popularity, criminals have seized the opportunity to illegally sell the drugs online, putting patients at risk.
These GLP-1 agonists are in high demand by patients; however, they are expensive and often not covered by insurance. In addition, some dosages of these approved drugs are on Food and Drug Administration's Drug Shortage List, meaning that the available supply cannot meet the current demand. As a result, some patients go online to find these popular medications. Illegal online sellers are exploiting this demand by offering substandard and falsified GLP-1 agonists to vulnerable patients. According to the Partnership for Safe Medicines, substandard and falsified Ozempic® has been found in at least 16 countries to date. In the report, NABP highlights the methods illegal actors use to sell substandard or falsified GLP-1 agonists:
- Criminals sell these drugs online without requiring a valid prescription and without the required pharmacy licenses.
- Some bad actors trick purchasers by mimicking legal sellers' websites, branding, or packaging.
- Others employ a non-delivery scheme, meaning patients never receive the goods they pay for online.
- Sellers may also try to skirt enforcement by advertising drugs as "peptides" with claims that they are for "research purposes only" and "not for human consumption."
Government agencies around the world are actively investigating illegal sellers, and online marketplaces and e-advertising platforms are working to remove illegal drug sellers from their platforms. NABP applauds the efforts of these agencies and organizations.
Learn how you can warn patients against illegal online sellers of GLP-1 agonists by reading the RogueRx Activity Report.
ROCKVILLE, MD and TULSA, OK — Health technology company DrFirst, and PatchRx, a medication adherence company, announced a partnership to close the gap between a healthcare provider’s recommended medication therapy and the patient’s actual medicine-taking behavior.
This collaboration aims to mitigate the health and economic impacts of medication non-adherence, which is linked to approximately 125,000 deaths and nearly $250 billion in healthcare costs annually in the U.S. By combining prescription fill data and remote monitoring data, DrFirst and PatchRx will provide a more accurate view of patient behavior, empowering care managers and quality improvement clinicians to prioritize, monitor, and intervene with high-risk patients for clinical quality improvement initiatives, such as value-based care, chronic care management, and medication therapy management programs.
“There’s a massive data gap in healthcare between when patients fill prescriptions and when patients actually take the medication, resulting in critical adherence oversights. Combining DrFirst’s prescription fill data with our daily adherence insight gives doctors a complete picture of how well a patient is following their prescribed medication regimen with unprecedented granularity,” said Andrew Aertker, co-founder and CEO of PatchRx. “With so many complex medication routines for behavioral health issues or chronic conditions like diabetes and hypertension, this collaboration will go a long way in providing the best technology to support those patients and deliver the precise data providers need to connect with patients proactively and personally.”
PatchRx’s patented, smart pill-bottle technology has gained widespread adoption with high levels of patient engagement. The unique cap fits on the underside of any size pill bottle, gathering information securely for the patient and the patient’s care team.
This technology complements DrFirst’s population risk management solution, which provides the most accurate and clinically actionable medication history for patients enrolled in medication management programs, including prescriptions patients purchase with cash, coupons, or pharmacy prescription savings plans.
“Timing is everything when it comes to effective treatment of complex conditions,” said G. Cameron Deemer, CEO of DrFirst. “Combining our comprehensive prescription fill data with remote monitoring data from PatchRx will give providers the information they need to identify patients who are off schedule with their medications and to intervene early to provide support and prevent health complications.”
WASHINGTON, DC — The Department of Health and Human Services (HHS) issued a final rule revising the administrative dispute resolution (ADR) process under the 340B program. This final rule will apply to all drug manufacturers and covered entities that participate in the 340B Program, addressing the requirements and procedures for the 340B Program’s administrative dispute resolution (ADR) process.
According to the American Hospital Association, the ADR process allows all 340B-covered entities — regardless of the size of the organization or monetary value of the claim — to address claims at dispute with drug companies.
"The final rule contains several important process improvements, including a clear timeline for when ADR decisions must be made and an opportunity for reconsideration when parties are dissatisfied with the initial ADR decision," AHA General Counsel Chad Golder said. "The AHA is particularly pleased that the final rule makes clear that an overcharge claim includes instances where a drug company has limited a hospital's ability to purchase 340B drugs at or below the 340B ceiling price. This rule will help hold drug companies accountable for their rampant abuses of the 340B program and the patients it serves."
“340B Health is pleased that HRSA’s (Health Resources & Services Administration) final rule aligns with several of our recommendations for revisions and clarifications to the agency’s proposed rule," Maureen Testoni, president and CEO of 340B Health, said."We are particularly encouraged by the final rule clarifying that a covered entity’s ADR claims can include accusations that a drug company has limited the ability to purchase drugs at or below the 340B ceiling price and removing a proposed amendment to block ADR consideration of a claim similar to an issue pending in federal court. HRSA’s removal of potential conflicts of interest and unnecessary legal barriers are additional positive steps that will simplify and streamline the dispute resolution process for the benefit of all participants.”
This rule, which may be viewed in full here, will come into effect on June 18, 2024.
CAMBRIDGE, MA – Takeda (NYSE:TAK) announced that the U.S. Food and Drug Administration (FDA) has approved ENTYVIO® (vedolizumab) subcutaneous (SC) administration for maintenance therapy in adults with moderately to severely active Crohn’s disease (CD) after induction therapy with intravenous (IV) ENTYVIO.1 The subcutaneous administration of ENTYVIO was also approved by FDA in September 2023 for the maintenance treatment of adults with moderately to severely active ulcerative colitis (UC) and is available in the U.S. as a single-dose prefilled pen (ENTYVIO Pen).*
The approval is based on the VISIBLE 2 Study (SC CD Trial), a Phase 3, randomized, double-blind, placebo-controlled trial, which assessed the safety and efficacy of an SC formulation of ENTYVIO as maintenance therapy in adult patients with moderately to severely active CD who had clinical response** at Week 6 following two doses of open-label vedolizumab intravenous therapy at Weeks 0 and 2.1 The primary endpoint was clinical remission*** at Week 52, which was defined as a total Crohn’s Disease Activity Index (CDAI) score of ≤150.
“Crohn’s disease is a complex and usually progressive disease for which an appropriate management plan is critical. My primary goal as a clinician is always to get patients to achieve remission. In VISIBLE 2, about half of patients treated with ENTYVIO SC achieved long-term clinical remission,” said Timothy Ritter, MD, senior medical director, Department of Research and Education, GI Alliance Research and assistant professor of medicine, TCU School of Medicine. “The data from VISIBLE 2 reaffirm the well-established efficacy profile of ENTYVIO, regardless of route of administration.”
In VISIBLE 2, a total of 409 patients were randomized at Week 6 in a double-blind fashion (2:1) to ENTYVIO 108 mg administered by SC injection or placebo every 2 weeks.1 Eligible patients included patients who had experienced an inadequate response to, loss of response to, or intolerance to at least one of the following: corticosteroids, immunomodulators (azathioprine, 6-mercaptopurine, or methotrexate), or tumor necrosis factor (TNF) blockers (including primary non-responders).
A statistically significant proportion of patients receiving ENTYVIO SC 108 mg maintenance therapy administered every 2 weeks achieved long-term clinical remission*** compared to patients receiving placebo (48% vs. 34%; p<0.01) at Week 52.1 In clinical studies, the ENTYVIO SC safety profile was generally consistent with the known safety profile of ENTYVIO IV, with the addition of injection site reactions (including injection site erythema, rash, pruritus, swelling, bruising, hematoma, pain, urticaria and edema) as an adverse reaction for ENTYVIO SC. The most common adverse reactions reported with ENTYVIO IV (incidence ≥3% and ≥1% higher than placebo) were nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, and pain in extremities.
“The approval of subcutaneous ENTYVIO in Crohn’s disease delivers on our goal of providing treatment options that can help patients achieve remission of their ulcerative colitis or Crohn’s disease, while also providing them flexibility and choice of route of administration. With ENTYVIO Pen, patients have the option of administering their maintenance treatment at home or on the go,” said Brandon Monk, senior vice president, head, U.S. Gastroenterology Business Unit, Takeda. “Our development of a subcutaneous option demonstrates Takeda’s commitment to meeting the very real needs of those living with gastrointestinal diseases.”
*Please refer to “U.S. FDA Approves Subcutaneous Administration of Takeda’s ENTYVIO® (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Ulcerative Colitis”, dated September 27, 2023.
**Clinical response is defined as a ≥70-point decrease in Crohn’s Disease Activity Index (CDAI) score from baseline (Week 0).1
***Clinical remission is defined as CDAI score of ≤150 at Week 52.1
INDIANAPOLIS, IN – Eli Lilly and Company (NYSE: LLY) announced positive topline results of the SURMOUNT-OSA phase 3 clinical trials that showed tirzepatide injection (10 mg or 15 mg) significantly reduced the apnea-hypopnea index (AHI) compared to placebo, achieving the primary endpoints. Percentage change in AHI was a key secondary endpoint in both studies. AHI records the number of times a person's breathing shows a restricted or complete block of airflow per hour of sleep and is used to evaluate the severity of obstructive sleep apnea (OSA) and the effectiveness of treatment outcomes. Tirzepatide is the only approved GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) treatment for chronic weight management, commercialized as Zepbound® in the U.S. and Mounjaro® in some global markets outside the U.S.
SURMOUNT-OSA Study 1 evaluated tirzepatide in adults with moderate-to-severe OSA and obesity who were not on positive airway pressure (PAP) therapy for 52 weeks. For the efficacy estimandi, at 52 weeks, tirzepatide led to a mean AHI reduction from baseline of 27.4 events per hour compared to a mean AHI reduction from baseline of 4.8 events per hour for placebo. In key secondary outcomes, tirzepatide led to a mean AHI reduction from baseline of 55.0% compared to 5.0% from baseline for placebo; tirzepatide also led to a mean body weight reduction of 18.1% from baseline, compared to 1.3% from baseline for placebo.
SURMOUNT-OSA Study 2 evaluated tirzepatide in adults with moderate-to-severe OSA and obesity who were on and planned to continue to use PAP therapy for 52 weeks. In this population for the efficacy estimand, at 52 weeks, tirzepatide led to a mean AHI reduction from baseline of 30.4 events per hour compared to a mean AHI reduction from baseline of 6.0 events per hour for placebo. In key secondary outcomes, tirzepatide led to a mean AHI reduction from baseline of 62.8% compared to 6.4% from baseline for placebo; tirzepatide also led to a mean body weight reduction of 20.1% from baseline, compared to 2.3% from baseline for placebo.
The weight loss observed at 52 weeks with tirzepatide (10 mg and 15 mg) across the two studies was nearly 20% in a patient population that was comprised of approximately 70% males, who are known to achieve less weight loss with incretin therapy than females.
OSA is a sleep-related breathing disorder characterized by complete or partial collapses of the upper airway during sleep, which can lead to apnea or hypopnea and a potential decrease in oxygen saturation and/or waking from sleep. OSA can have serious cardiometabolic complications, contributing to hypertension, coronary heart disease, stroke, heart failure, atrial fibrillation and type 2 diabetes.
"OSA impacts 80 million adults in the U.S., with more than 20 million living with moderate-to-severe OSA. However, 85% of OSA cases go undiagnosed and therefore untreated," said Jeff Emmick, MD, Ph.D., senior vice president, product development, Lilly. "Addressing this unmet need head-on is critical, and while there are pharmaceutical treatments for the excessive sleepiness associated with OSA, tirzepatide has the potential to be the first pharmaceutical treatment for the underlying disease."
LOUISVILLE, KY — ScionHealth announced today they will begin purchasing certain bulk drugs from Mark Cuban’s Cost Plus Drug Company (“Cost Plus Drugs”) and delivered to Safecor Health’s SafecorLogics program. The integrated approach, combining the expertise of three organizations, will enable ScionHealth to deliver exceptional value to patients while ensuring the sustainability of its healthcare delivery model.
Cost Plus Drugs was launched in January 2022 with the mission of providing cheaper pharmaceuticals by eliminating middlemen and offering a transparent pricing model. The company’s Cost Plus Drugs Marketplace launched in 2023 to bring this same philosophy to healthcare business purchasers. “Everyone should be able to access their prescriptions at affordable and transparent prices,” said Dr. Alexander Oshmyansky, CEO at Cost Plus Drugs. “We are thrilled to work with ScionHealth as one of our initial health system partnerships and look forward to our work together with their team and Safecor Health.”
Since September of 2023, ScionHealth has worked with Safecor Health as a strategic supply chain partner through Safecor Health’s SafecorLogics program. SafecorLogics was developed to help healthcare systems centralize their own unit-dose supply chains, giving them greater cost savings and mitigating waste while optimizing staffing and operations. ScionHealth expanded its utilization of the program in January of 2024.
“Across the industry and particularly in hospital settings, we are facing the challenges of rising drug and supply costs and navigating staffing shortages,” said Rob Jay, ScionHealth’s Chief Executive Officer. “ScionHealth is continually looking for innovative approaches to address these issues while advancing the delivery of high-quality, patient-centered care and well-being to our communities. SafecorLogics has already been an effective solution to help us address these challenges. Now, by introducing Cost Plus Drugs, we are confident we’ll see even more success managing drug costs and enhancing care delivery across the ScionHealth network.”
Steve Fischbach, Safecor Health’s Chief Executive Officer, echoed this sentiment, saying “We are proud to partner with innovative companies like ScionHealth and we are excited to expand that partnership with products from Cost Plus Drugs. It’s a great fit for the SafecorLogics program and we’re sure it will lead to meaningful savings for ScionHealth.”
The drugs ScionHealth purchases in bulk from Cost Plus Drugs will be delivered to Safecor Health's unit-dose packaging centers where they will be packaged, stored, and shipped same-day as requested by ScionHealth's locations.
Anders Hedlund is currently the CEO of Nolsterby Invest AB, the largest shareholder in Pharmacolog. Nolsterby Invest AB is an investment company in the healthcare sector and has been invested in Pharmacolog since 2017. Since 2023, Anders Hedlund is also a current Board Member of Pharmacolog, a position he plans to maintain.
Erik Hedlund, Chairman of the Board and main owner of Pharmacolog: "We are in a transformational process to become a serial acquirer within the healthcare sector. There is a lot of work to be done although we have made progress during the quarter by, for instance, divesting the Druglog product line. Recently, we also announced our intention to change the name of the company. Anders Hedlund’s main task will be to lay the ground for the new business direction. His extensive experience and network in the healthcare and financial industry make him suitable for this task.”
IRVING, TX – Vizient, Inc. released recommendations focused on mitigating common risks, identifying national guidelines and utilizing existing resources to ensure preparedness for an active shooter event. The recommendations were made by a task force of 40 Vizient network executives from 27 organizations across the country. The recommendations and rationales bring attention to organizational tactics that were found by the task force to be lacking or inconsistent. View active shooter preparedness resources.
"It is an uncomfortable topic to discuss but it is vital that hospitals address the issue of a potential active shooter event," said Susan Chishimba, Vizient Member Networks senior director. "Planning for the unthinkable will invariably save lives."
The recommendations are based in part on the results of a recent Vizient provider customer health system survey that revealed disparities in active shooter protocols. While 98% of hospital system respondents said they have enacted an active shooter protocol, preparedness varied. Only 24% have discussed a dedicated plan to ensure continuity of care for critically ill patients. Of those, very few use a "secure-preserve-defend" doctrine in which staff first prioritize locking down or barricading their patient care areas. The results of the survey are published in the American Journal of Disaster Medicine. View a summary of the survey findings, Assessing Active Shooter Preparedness in U.S. Hospital Systems.
The recommendations from the task force focus on appropriate communication, secure access, management of critically ill patients who are unable to run, hide and fight, and include tactics for addressing post-event trauma. The online resources, which comprise recommendations and rationales for communication, physical security, plan and response, drills and simulations and a post-event response, include:
- Using appropriate language when broadcasting an event, with attention to both internal and external communication.
- Integrating access control, video surveillance, alarms, and other supportive technology to reduce the risk of active shooters gaining access to secure areas.
- Investing in shot-detection technology that would alert local law enforcement as soon as shots are fired.
- Considering the need for hemorrhage control procedure and supplies as a critical element of an organization’s response plan.
- Focusing on the importance of post-event recovery in order to restore safety, rebuild confidence and foster resilience.
"Active shooter events are a tragic and unfortunate reality," said Jodi Eisenberg, associate vice president, Vizient Member Networks. "It’s critically important to have a comprehensive plan in place — even if it’s one you hope you never have to use."
TOKYO and BASKING RIDGE, NJ – Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/Nasdaq: AZN) Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted in the U.S. for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior systemic therapy for unresectable or metastatic disease.
Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and AstraZeneca.
The Prescription Drug User Fee Act (PDUFA) date, the U.S. Food and Drug Administration (FDA) action date for its regulatory decision, is January 29, 2025.
The BLA is based on results from the pivotal TROPION-Breast01 phase 3 trial, which were presented at a Presidential Symposium at the European Society for Medical Oncology (#ESMO23) 2023 Congress and in an oral presentation at the 2023 San Antonio Breast Cancer Symposium (#SABCS23). In the trial, datopotamab deruxtecan demonstrated a statistically significant and clinically meaningful improvement for the dual primary endpoint of progression-free survival (PFS) compared to investigator’s choice of chemotherapy in patients with unresectable or metastatic HR positive, HER2 negative breast cancer previously treated with endocrine-based therapy and at least one systemic therapy. For the dual primary endpoint of overall survival (OS), interim results numerically favored datopotamab deruxtecan over chemotherapy but were not mature at the time of data cut-off. The trial is ongoing and OS will be assessed at future analyses. The safety profile of datopotamab deruxtecan was consistent with that observed in other ongoing trials with no new safety concerns identified. The most common grade 3 or higher treatment-related adverse events in the datopotamab deruxtecan and chemotherapy arms, respectively, were neutropenia (1% vs. 31%), stomatitis (6% vs. 3%), fatigue (2% vs. 2%) and anemia (1% vs. 2%). 2
“The FDA’s acceptance of the BLA brings us closer to providing patients with previously treated HR positive, HER2 negative breast cancer an alternative option to conventional chemotherapy earlier in the metastatic setting,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “Following our recently accepted application for advanced nonsquamous non-small cell lung cancer in the U.S., along with additional regulatory reviews underway in China, the EU, Japan and other regions, we are working swiftly to bring datopotamab deruxtecan as a potential new treatment option to patients around the world.”
“Despite marked progress in the treatment of HR positive, HER2 negative breast cancer, most patients with advanced disease develop endocrine resistance and face the prospect of one or several lines of chemotherapy,” said Susan Galbraith, MBBChir, PhD, Executive Vice President, Oncology R&D, AstraZeneca. “If approved, datopotamab deruxtecan has the potential to provide these patients an efficacious and better tolerated alternative to conventional chemotherapy.”
An additional BLA for datopotamab deruxtecan based on results from the pivotal TROPION-Lung01 phase 3 trial is under review in the U.S. for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have received prior systemic therapy. Additional regulatory submissions for datopotamab deruxtecan in lung and breast cancer are underway globally.
BRIDGEWATER, NJ - Amneal Pharmaceuticals, LLC. (Amneal) is voluntarily recalling 4 lots (see table below) of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL packaged in 80 mL, 150 mL, or 300 mL pack sizes, to the Consumer Level. Some bottles may have been overfilled which can result in an over potent dosing regimen. The recommended maximum daily dose allowance for this product is up to 2gm/day and patients prescribed a dosing regimen of 500 mg/10mL would exceed this daily allowance, which may be harmful to patients with renal insufficiency. The error occurred during the manual bottle filling stage of manufacturing.
Risk Statement: Adult patients who are prescribed the maximum daily dose of up to 2 grams per day of Vancomycin Hydrochloride for oral solution, USP 250 mg/5mL, may receive up to 4 grams of oral vancomycin per day because of the overfilled bottle. Some patients with inflammatory disorders of the intestinal mucosa also may have significant systemic absorption of vancomycin. These patients may be at risk for the development of adverse reactions associated with higher doses of vancomycin oral solution. Worsening renal function could be associated with electrolyte abnormalities such as high potassium leading to cardiac arrest. To date, Amneal has not received any reports of adverse events that have been confirmed to be directly related to this recall.
Vancomycin Hydrochloride for Oral Solution, USP, 250mg/5mL, is administered orally for treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic- associated pseudomembranous colitis caused by C. difficile.
The Vancomycin HCl for Oral Solution, USP, 250 mg/5mL subject to the recall, are identified by the NDC numbers stated on the product label. The following lot numbers of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL are included in this recall.
Vancomycin Hydrochloride for Oral Solution, USP, 250mg/5mL
NDC No. | Lot | Expiration Date | Pack Size |
69238-2261-3 | 22613003A | 09/2025 | 80 mL |
69238-2261-7 | 22613004A | 09/2025 | 150 mL |
69238-2261-7 | 22613005A | 09/2025 | 150 mL |
69238-2261-5 | 22613005B | 09/2025 | 300 mL |
The affected Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL lots were distributed Nationwide in the USA directly to Wholesalers and Distributors. The Lots were distributed between 11/09/2023 and 2/20/2024.
Amneal is notifying its direct customers via mail (UPS Standard Overnight) by mailing a recall notification letter and is arranging for the return of the recalled products. Anyone with an existing inventory of the product being recalled should examine the product and quarantine any of the recalled lots immediately.
Customers who purchased the impacted product directly from Amneal may call Amneal at
1 833-582-0812 Monday – Friday, 8:00 am – 5:00 pm, EST, or email to Vancomycin_Recall@amneal.com for further information.
Retailers who have Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL, which are being recalled, should examine their inventory and cease dispensing any of the impacted lots and contact Amneal directly via email at Vancomycin_Recall@amneal.com or by telephone 1833-582-0812 Monday – Friday, 8:00 am – 5:00 pm, EST, for information and instructions for the product return.
Consumers who have Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/mL should examine the bottle, cease using the product if the lot number is listed on the recall and contact Amneal via telephone or email for recall information and for product return instructions. Consumers may call Amneal at 1 833-582-0812 Monday – Friday, 8:00 am – 5:00 pm, EST, or email Vancomycin_Recall@amneal.com for further information and instructions for the product return. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
If you would like to report any adverse reactions or quality problems experienced with the use of this product you may contact Amneal Drug Safety by phone at 1-877-835-5472, Monday - Friday, 8:00 am – 6:00 pm, EST, or via e-mail at DrugSafety@amneal.com.
Any adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call
1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178