Part 2 of this topic discusses new legislation regarding dangerous drugs, defective toys and sexual predators using the internet to prowl and prey. The information herein is set forth in press releases issued by the governor’s office. Proposed legislation designed to protect patients from medical malpractice was discussed in Part 1 of this blog. Governor David A. Paterson has proposed legislation to limit the influence of pharmaceutical manufacturers over prescription decisions by banning gifts and payments from drug companies to physicians and other prescribers in excess of $50 per year; these actions are to be monitored by pharmacy benefit managers (PBMs).
The bill would also require practitioners who make presentations at Continuing Medical Education (CME) events to disclose any financial relationship they have with drug companies. In addition, the bill would increase transparency and promote competition among pharmacy benefit managers (PBMs) by requiring them to disclose information to health plans, doctors and patients.
The bill addresses reported problems involving drug-makers’ marketing, a topic that has come under U.S. Senate scrutiny. The bill contains exemptions from the gift ban for drug samples and discounts and for reasonable payments to physicians and other prescribers that are made in connection with bona fide research or educational activities. Such payments must be disclosed by the manufacturer and the prescriber to the Department of Health.
The bill also imposes disclosure requirements upon PBMs, which are private entities that administer almost all prescription drug insurance plans offered by health benefits providers. The PBMs must disclose to their client health plans information including:
(1) the actual utilization of drugs by the health plans participants;
(2) every policy or practice of the PBM that presents an actual or potential conflict of interest with the health plan;
(3) any increase in the net price to the health plan for a covered drug and the reason for the increase;
(4) all contracts and agreements entered into by the PBM with a network pharmacy and with any pharmaceutical manufacturer.
The bill requires notification to patients and the provision of relevant clinical and financial information to prescribers before drug switches can be made to prevent PBMs from switching patients to more expensive drugs without the patients knowledge and without providing adequate information to the practitioner.
Governor Paterson’s submitted legislation regarding unsafe toys strengthens consumer notifications and requires warning labels for toys containing lead, magnets and liquids. During the summer of 2007, the Consumer Protection Board (CPB), along with other State agencies, conducted toy recall sweeps to investigate compliance with Consumer Product Safety Commission (CPSC) recalls. The inspectors visited and contacted approximately 2,800 retail establishments and thrift shops throughout New York, and identified roughly 400 stores that carried one or more of the recalled items.
The legislation is designed to remedy certain deficiencies in existing law. One deficiency is that once a product has been recalled, it is often very difficult for the manufacturer and the seller to notify all of the consumers who have purchased the item. This often results in recalled items such as used toys, nursery products, cribs, playpens and other similar products handed-down between siblings or acquired at secondhand or thrift stores, being unwittingly purchased at these locations.
In addition, currently there is no prohibition against the sale or distribution of children’s products or durable juvenile products that have been the subject of a recall by the U.S. Consumer Product Safety Commission (CPSC), nor is there an effective system for notifying individuals of such recalls. There is also no requirement for labeling of children’s products or durable juvenile products that contain lead, magnets or potentially hazardous liquids.
This bill seeks to address these problems in several ways. In particular, the bill:
- Requires that manufacturers of durable juvenile products (which as defined include cribs, car seats, high chairs, playpens and other similar durable products for children under five years old) must include a product safety owner card with the product at the time of original purchase by consumers;
- Requires manufacturers and importers of childrens products and durable juvenile products to notify consumers, distributors, retailers, the State Attorney General and the CPB of any recalls or warnings;
- Provides that commercial dealers (i.e., manufacturers, importers, distributors and wholesalers), after receiving notice of a recall or warning, must:
(1) remove the recalled product from their shelves and websites;
(2) contact the initial purchaser of the product if possible; and
(3) post recall notices and warnings in a conspicuous manner;
- Requires appropriate children’s products and durable juvenile products to have labels indicating the manufacturers and importers name and contact information, as well as lot/batch information if applicable, either on the product or on its packaging;
- Requires disclosure of lead paint, magnets and liquids in children’s products and durable juvenile products; and
- Authorizes the CPB and the Attorney General to enforce these requirements.
The Electronic Security and Targeting of Online Predators Act (e-STOP), signed into law by Governor Paterson and effective immediately, was proposed by Attorney General Andrew M. Cuomo to establish vital protections against sexual predators so that users of the Internet can more safely surf the Web.
Under New York States Sex Offender Registration Act (SORA), the Division of Criminal Justice Services (DCJS) maintains a computer registry of the names and addresses of convicted sex offenders, and that information is made available to the public. Nonetheless, sex offenders remain free to create screen names and access social networking sites used by children, and our laws do not effectively prevent that use. e-STOP seeks to address that problem by:
(1) requiring convicted sex offenders to register their Internet screen names with the Sex Offender Registry;
(2) allowing social networking web sites to obtain those screen names in order to prohibit those account holders from accessing web sites on which they could contact children; and
(3) mandating that dangerous convicted sex offenders who are serving a term of probation, conditional discharge or parole be prohibited from using the Internet to contact children.
As a result of e-STOP, DCJS will begin sending out approximately 25,000 letters to sex offenders who are in the Sex Offender Registry advising them that they must register any Internet and email accounts used for purposes of online chatting, instant messaging or social networking.
DCJS will advise offenders that if they change their email address or create a new online profile, they must notify the state within 10 days and failure to comply with the registration requirements is a felony. Of course, it is highly doubtful that all sexual predators will voluntarily register. But at least this law is an important step in the right direction.