Pharmaceutical Executive
One of the Hatch-Waxman Act's authors opposes proposed changes to the 1984 legislation.
One of the Hatch-Waxman Act's authors opposes proposed changes to the 1984 legislation. At a Senate hearing last month, Senator Orrin Hatch (R, Utah) said he disagrees with proposals to eliminate the 30-month "stay" on FDA approval of contested generic products or to revise the 180-day exclusivity period for new generics. Those provisions are key elements of a bill sponsored by Senators Charles Schumer (D, New York) and John McCain (R, Arizona) that aims to end tactics allegedly used by innovator companies to delay generic competition.
However, Representative Henry Waxman (D, California) indicated that he may not agree with Hatch. Such abuses of the system by brand-name companies have upset the "appropriate balance" established in the original bill, Waxman states in a letter to the Senate Health, Education, Labor and Pensions (HELP) Committee.
Hatch says Congress must go slow in determining "how to restore that balance." At the HELP panel hearing chaired by Senator Ted Kennedy (D, Massachusetts), Schumer blasted brand-name companies for filing weak or invalid patents and for making anticompetitive deals designed to extend monopolies. The main charge is that innovators file late patents on minor innovations, such as new dosing methods, largely to keep generics off the market.
Industry lawyers counter that such patents seldom prevent generic competitors from making original products, just from making the new formulations. The charges and countercharges have generated a good deal of skepticism about all claims in the debate.
Hatch's call for Congress to get the facts before changing the law is likely to carry the day. Hatch suggests other possible changes to the generics bill, such as dropping the 180-day exclusivity policy and linking elimination of the 30-month stay with that of the Bolar amendment, which permits generics makers to access innovators' data before patent expiration. Hatch wants hard information about the occurance of multiple consecutive 30-month stays and about the frequency of suits that challenge later-issued patents.
The Federal Trade Commission is expected to issue a report on those issues this summer. One question is whether Hatch-Waxman should be revised to include generic biologicals, a move opposed by innovator companies. Despite Hatch's call for proceeding thoughtfully, sponsors of McCain-Schumer are promoting the bill as a way to reduce expenditures for prescription therapies. This fall, members of Congress may jump on the generic reform bandwagon as an easy way to do "something" about soaring medical costs.
Beyond the Prescription: Pharma's Role in Digital Health Conversations
April 1st 2025Join us for an insightful conversation with Jennifer Harakal, Head of Regulatory Affairs at Canopy Life Sciences, as we unpack the evolving intersection of social media and healthcare decisions. Discover how pharmaceutical companies can navigate regulatory challenges while meaningfully engaging with consumers in digital spaces. Jennifer shares expert strategies for responsible marketing, working with influencers, and creating educational content that bridges the gap between patients and healthcare providers. A must-listen for pharma marketers looking to build trust and compliance in today's social media landscape.
Beyond the Prescription: The Role Pharma Plays in Digital Health Conversations
April 1st 2025As social media continues to influence healthcare communication, it presents both challenges and opportunities for the pharmaceutical industry. In this interview, Jennifer Harakal of Canopy Life Sciences discusses balancing compliance with effective digital engagement to build trust and facilitate meaningful healthcare conversations.
Beyond the Prescription: Pharma's Role in Digital Health Conversations
April 1st 2025Join us for an insightful conversation with Jennifer Harakal, Head of Regulatory Affairs at Canopy Life Sciences, as we unpack the evolving intersection of social media and healthcare decisions. Discover how pharmaceutical companies can navigate regulatory challenges while meaningfully engaging with consumers in digital spaces. Jennifer shares expert strategies for responsible marketing, working with influencers, and creating educational content that bridges the gap between patients and healthcare providers. A must-listen for pharma marketers looking to build trust and compliance in today's social media landscape.
Beyond the Prescription: The Role Pharma Plays in Digital Health Conversations
April 1st 2025As social media continues to influence healthcare communication, it presents both challenges and opportunities for the pharmaceutical industry. In this interview, Jennifer Harakal of Canopy Life Sciences discusses balancing compliance with effective digital engagement to build trust and facilitate meaningful healthcare conversations.
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