Requires the commissioner of health to establish and publish a list of generic drug products; repealer

Summary of specific provisions

Section one repeals paragraph (o) of subdivision 1 of section 206 of the public health law (PHL).

Section two adds a new section 280-a, named "generic drug products", to the PHL. The provisions included in subdivision one are taken from paragraph (o) of subdivision one of section 205 of the PHL, which has been repealed. This new subdivision provides that the health commissioner shall establish a list of drug products, which must be certified or approved and evaluated as therapeutically and pharmaceutically equivalent by the Federal Food and Drug Administration. Subdivision two provides that the manufacturer of a generic drug product shall make available to the department of health the biopharmaceutic studies and summaries (including bioequivalence data and incidence of adverse events) and associated analytical methods (including dissolution data and test methods) provided to the FDA as part of the application for such generic drug product. The department shall make such information freely and publicly available on its website.

Section 3 and section 4 change the references to paragraph (o) of subdivision 1 of section 206 of the PHL in the Education Law.

Section 5 provides the effective date.

Justification

New York State Law (paragraph (o) of subdivision 1 of section 206 of the Public Health Law) provides that the health commissioner shall establish and maintain a list of generic drug products, which must meet specified conditions. The bill repeals this paragraph and transfers its language to a new section (280-a) of the PHL, named "generic drug products. This way, the provisions related to generic drugs are easily accessible.

The bill also introduces a new provision (subdivision 2 of the new section 208-a) to make relevant information related to generic drug products freely and publicly available.

The Center for Drug Evaluation and Research defines a generic drug as a drug product that is comparable to a brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use. Generic drugs are approved by the FDA and represent an affordable option for users. To receive approval by the FDA, generic drug manufacturers have to submit specified documents and reports, proving that their drug is bioequivalent to the respective brand name drug. The information that producers and manufacturers provide to the FDA is not publicly

available. For most generic drugs, consumers can access such information only by going through a formal FOIL request. This process can be extremely difficult and time-consuming.

Moreover, the availability of such information is extremely valuable. The FDA has to process thousands of drug applications and mostly relies on studies submitted by the drug producers or manufacturers when making bioequivalence assessments.

In 2008, the FDA declared Teva's Budeprion XL 300 (generic version of the antidepressant Wellbutrin XL 300 mg) as safe and effective. However, consumers started to complain about the generic version of Wellbutrin: after switching to the generic formulation, many reported symptoms such as headaches, irritability, nausea, and return of depression.

In 2012, the FDA announced that the Teva's generic drug is NOT bioequivalent to the brand name drug. The reversal was based on a FDA bioequivalence study which found Budeprion XL 300 achieved only 75%. of the maximum drug concentration attained with Wellbutrin XL 300 mg (potentially explaining the return of depression in patients switched to Budeprion XL 300). Teva's product released much of its drug earlier than Wellbutrin. The dissolution rate greatly affects how a drug is released in the human body. This ultimately affects the drug effectiveness. The new results obtained by the FDA closely matched the results of independent organizations that tested the two drugs for bioequivalence.

The biopharmaceutic studies and summaries, dissolution data, and test methods provided to the FDA by generic drugs producers must be available. This way, such information can be reviewed and analyzed by experts who can conduct independent evaluations of the drugs.

The intent of the bill is to encourage transparency, in order to protect consumers. Certainly, consumers should have the option to have their prescription filled with a generic product, particularly since generics often cost less than brand name drugs. However, consumers must be informed of the drawbacks, if any, of taking a generic drug instead of the brand name drug. Consumers have the right to know what the differences between brand and generic drugs are and decide, with their physicians and pharmacists, whether the generic product is appropriate for them.

Prior legislative history

This is a new bill.

Fiscal implications

None to the State.

Effective date

This act shall take effect on the ninetieth day after it shall have become a law.