California compliance policy
summary and declaration
Compliance Policy Summary
It is the policy of Metuchen Pharmaceuticals, LLC ("Metuchen") to comply with all applicable laws and regulations and industry standards, including the PhRMA Code on Interactions with Healthcare Professionals and the Compliance Program Guidance for Pharmaceutical Manufacturers developed by the U.S. Department of Health and Human Services Office of the Inspector General (the "OIG Guidance"). Our Comprehensive Compliance Program incorporates the following elements from the OIG Guidance:
- Written Policies and Procedures
- Compliance Committee
- Effective Training and Education
- Effective Lines of Communication
- Internal Monitoring and Auditing
- Enforcement Through Discipline Pursuant to Published Guidelines; and
- Prompt Response and Corrective Action for Detected Problems
Metuchen sales and marketing personnel interact with healthcare professionals to provide them with information about Metuchen products and other relevant educational or scientific topics. Metuchen believes that these interactions provide educational value to healthcare professionals and help benefit patients. In connection with certain of these interactions, Metuchen may provide promotional materials, or educational items intended to benefit a patient or related to a healthcare professionals' practice. Metuchen may also on occasion offer modest meals to healthcare professionals in connection with educational presentations. The PhRMA Code allows pharmaceutical companies to provide "items designed primarily for the education of patients or healthcare professionals if the items are not of substantial value ($100 or less) and do not have value to healthcare professionals outside of his or her professional responsibilities." On occasion Metuchen may approve the distribution of an educational item to a healthcare professional in accordance with the PhRMA Code standards. Metuchen's Comprehensive Compliance Program is designed to ensure that these activities are conducted in lawful manner.
California Health and Safety Code §§ 119400-119402 requires pharmaceutical companies to make available their Comprehensive Compliance Program and to set an annual aggregate limit on certain promotional expenditures provide to a healthcare professional as defined under the California law.
Annual Spend Limit
Subject to this California law, Metuchen has determined that the annual aggregate limit on covered promotional expenditures in California is set at $500.00 per covered healthcare professional for each calendar year. This limit may be revised by Metuchen from time to time. It is important to note that this annual dollar limit is an upper limit. It is not an accurate representation of the average value of gifts, promotional materials, items or activities that Metuchen may provide generally to a healthcare professional. The average could be a lower amount. In accordance with the law, certain items and payments are excluded in determining whether the annual limit has been met. The annual limit does not include the value of:
- Drug samples provided to healthcare professionals intended for free distribution to patients;
- Financial support for continuing medical education forums;
- Financial support for health educational scholarships; and
- Payments for legitimate professional services, including professional speaking, advising, consulting, training or market research services, that are based on the fair market value of the services provided.
Declaration of Compliance
Metuchen declares, in good faith, that Metuchen is in substantial compliance with its Comprehensive Compliance Program and the requirements of California Health and Safety Code §§ 119400-119402. Our declaration is based upon information available during the twelve month period from January 1, 2017 through December 31, 2017. The next declaration will be based upon information captured beginning January 1, 2018.
As appropriate and consistent with applicable law, Metuchen will amend and make conforming changes to its Comprehensive Compliance Program. Metuchen is committed to assessing ongoing compliance with its Comprehensive Compliance Program. A copy of the Comprehensive Compliance Program and this written declaration can be requested by calling 866-453-0581.
STENDRA Use and Important Risk Information
STENDRA® (avanafil) is a prescription medicine used to treat erectile dysfunction (ED). STENDRA is not for use in women or children. It is not known if STENDRA is safe and effective in women or children under 18 years of age.
Do not take STENDRA if you:
- take medicines called nitrates, which are used to treat chest pain (angina); use street drugs called "poppers," such as amyl nitrate and butyl nitrate; take medicines called guanylate cyclase stimulators, which include Adempas® (riociguat), a medicine that treats pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension; or are allergic to avanafil or any of the ingredients in STENDRA
Discuss your health with your healthcare provider to ensure you are healthy enough for sex. If you have symptoms such as chest pain, dizziness, or nausea during sex, stop sexual activity and get medical help right away.
STENDRA can cause serious side effects. Uncommonly reported side effects include:
- an erection that will not go away (priapism). If you have an erection that lasts more than 4 hours, get medical help right away
- sudden vision loss in 1 or both eyes. Sudden vision loss in 1 or both eyes can be a sign of a serious eye problem called non-arteritic anterior ischemic optic neuropathy (NAION). It is uncertain whether PDE5 inhibitors directly cause vision loss. Stop taking STENDRA and call your healthcare provider right away if you have sudden vision loss in 1 or both eyes
- sudden hearing decrease or hearing loss. Some people may also have ringing in their ears (tinnitus) or dizziness
Before you take STENDRA, tell your healthcare provider if you:
- have or have had heart problems such as a heart attack, irregular heartbeat, angina, or heart failure; have had heart surgery within the last 6 months; have had a stroke; have low blood pressure, or high blood pressure that is not controlled; have a deformed penis shape
- have had an erection that lasted for more than 4 hours; have problems with your blood cells, such as sickle cell anemia, multiple myeloma, or leukemia; have retinitis pigmentosa, a rare genetic (runs in families) eye disease; have ever had severe vision loss, including an eye problem called non-arteritic anterior ischemic optic neuropathy (NAION); have bleeding problems; have or have had stomach ulcers; have liver problems; have kidney problems or are having kidney dialysis; or have any other medical conditions
Tell your healthcare provider about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. STENDRA may affect the way other medicines work, and other medicines may affect the way STENDRA works, which may cause side effects. Especially tell your healthcare provider if you take any of the following:
- medicines called nitrates
- medicines called guanylate cyclase stimulators, such as riociguat
- medicines called HIV protease inhibitors, such as ritonavir (Norvir®), indinavir (Crixivan®), saquinavir (Fortavase® or Invirase®), or atazanir (Reyataz®)
- some types of oral antifungal medicines, such as ketoconazole (Nizoral®) and itraconozale (Sporanox®)
- some types of antibiotics, such as clarithromycin (Biaxin®), telithromycin (Ketek®), or erythromycin
- medicines called alpha-blockers. These include terazosin (Hytrin®), tamsulosin HCl (Flomax®), doxazosin (Cardura®), prazosin HCl (Minipress®), alfuzosin HCl (UroXatral®), dutasteride and tamsulosin HCl (Jalyn®), or silodosin (Rapaflo®). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. In some patients, the use of STENDRA with alpha-blockers can lead to a drop in blood pressure or fainting
- other medicines that treat high blood pressure
- other medicines or treatments for ED
You should not drink too much alcohol (for example, more than 3 glasses of wine or 3 shots of whiskey) when taking STENDRA, as this can lead to increased chances of headache, dizziness, increased heart rate, or lowered blood pressure.
STENDRA does not protect against sexually transmitted diseases, including HIV.
The most common side effects of STENDRA are headache, flushing, stuffy or runny nose, sore throat, and back pain.
Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of STENDRA. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA by calling 1-800-FDA-1088, or at www.fda.gov/medwatch.