California Declaration Of Compliance

Compliance Policy Summary

It is the policy of Akrimax Pharmaceutical, LLC (“Akrimax”) 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

Akrimax sales and marketing personnel interact with healthcare professionals to provide them with information about Akrimax products and other relevant educational or scientific topics. Akrimax believes that these interactions provide educational value to healthcare professionals and help benefit patients. In connection with certain of these interactions, Akrimax may provide promotional materials, or educational items intended to benefit a patient or related to a healthcare professionals’ practice. Akrimax 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 Akrimax may approve the distribution of an educational item to a healthcare professional in accordance with the PhRMA Code standards. Akrimax’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, Akrimax 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 Akrimax 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 Akrimax 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

Akrimax declares, in good faith, that Akrimax 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, 2016 through December 31, 2016. The next declaration will be based upon information captured beginning January 1, 2017.

Conclusion

As appropriate and consistent with applicable law, Akrimax will amend and make conforming changes to its Comprehensive Compliance Program. Akrimax 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 973-597-6202.

TIROSINT WARNING

WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS

Thyroid hormones, including TIROSINT, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss.

In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction.

Larger doses may produce serious or even life threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects.

Tirosint Important Product Information

Levothyroxine sodium is used for the following indications: Please click here for full Prescribing Information, including Boxed Warning. Hypothyroidism: As a replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. Specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism. Primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from effects of surgery, radiation, or drugs, with or without the presence of goiter.

CONTRAINDICATIONS

Levothyroxine is contraindicated in patients with untreated subclinical (suppressed serum TSH level with normal T3 and T4 levels) or overt thyrotoxicosis of any etiology and in patients with acute myocardial infarction. Levothyroxine is contraindicated in patients with uncorrected adrenal insufficiency since thyroid hormones may precipitate an acute adrenal crisis by increasing the metabolic clearance of glucocorticoids. TIROSINT is contraindicated in patients with hypersensitivity to any of the inactive ingredients in TIROSINT capsules. TIROSINT is also contraindicated for anyone who may be unable to swallow a capsule (e.g., infants, small children).

WARNINGS

In patients with nontoxic diffuse goiter or nodular thyroid disease, particularly the elderly or those with underlying cardiovascular disease, levothyroxine sodium therapy is contraindicated if the serum TSH level is already suppressed due to the risk of precipitating overt thyrotoxicosis. If the serum TSH level is not suppressed, TIROSINT should be used with caution in conjunction with careful monitoring of thyroid function for evidence of hyperthyroidism and clinical monitoring for potential associated adverse cardiovascular signs and symptoms of hyperthyroidism.

PRECAUTIONS

Effects on bone mineral density – In women, long term levothyroxine sodium therapy has been associated with increased bone resorption, thereby decreasing bone mineral density, especially in post-menopausal women on greater than replacement doses or in women who are receiving suppressive doses of levothyroxine sodium. The increased bone resorption may be associated with increased serum levels and urinary excretion of calcium and phosphorous, elevations in bone alkaline phosphatase and suppressed serum parathyroid hormone levels. Therefore, it is recommended that patients receiving levothyroxine sodium be given the minimum dose necessary to achieve the desired clinical and biochemical response.

Patients with underlying cardiovascular disease – Exercise caution when administering levothyroxine to patients with cardiovascular disorders and to the elderly in whom there is an increased risk of occult cardiac disease. In these patients, levothyroxine therapy should be initiated at lower doses than those recommended in younger individuals or in patients without cardiac disease and it should be noted that unlike levothyroxine sodium tablets, TIROSINT capsules cannot be cut in half. If cardiac symptoms develop or worsen, the levothyroxine dose should be reduced or withheld for one week and then cautiously restarted at a lower dose. Overtreatment with levothyroxine sodium may have adverse cardiovascular effects such as an increase in heart rate, cardiac wall thickness, and cardiac contractility and may precipitate angina or arrhythmias. Patients with coronary artery disease who are receiving levothyroxine therapy should be monitored closely during surgical procedures, since the possibility of precipitating cardiac arrhythmias may be greater in those treated with levothyroxine. Concomitant administration of levothyroxine and sympathomimetic agents to patients with coronary artery disease may precipitate coronary insufficiency.

ADVERSE REACTIONS

Adverse reactions associated with levothyroxine therapy are primarily those of hyperthyroidism due to therapeutic overdosage such as fatigue, increased appetite, weight loss, heat intolerance, fever, excessive sweating, and other adverse reactions. This is not an exhaustive list. Please refer to TIROSINT’s full Prescribing Information for a more comprehensive list of adverse reactions associated with hyperthyroidism.