To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes.
Impact
If enacted, HB1051 would amend existing provisions on exclusivity rules under the Food, Drug, and Cosmetic Act. The most critical aspect of this legislation is the enforcement of a 180-day exclusivity period for the first applicant that is approved but does not initiate marketing within the prescribed timeline. Subsequently, this bill allows for other applicants to jump ahead in the approval line under specific conditions. The intention behind this amendment is to prevent stifling competition caused by delays in commercial marketing from initial applicants, thereby fostering quicker access to generic medications in the healthcare market.
Summary
House Bill 1051 seeks to amend the Federal Food, Drug, and Cosmetic Act, specifically addressing the protocol for approving abbreviated new drug applications (ANDAs). The bill is designed to streamline the process in cases where the first applicant fails to commence commercial marketing within a specific period, effectively allowing subsequent applicants to proceed without being held back by the initial applicant's inaction. This legislative move is significant as it attempts to enhance market responsiveness and availability of generic drugs, which could ultimately benefit consumers by increasing competition and lowering drug prices.
Contention
There could be potential contention surrounding the bill, particularly from stakeholders in the pharmaceutical industry. Proponents argue that the bill supports public health by promoting timely access to crucial medications, while critics may raise concerns about balancing the interests of patent holders and original drug manufacturers with the need for generic alternatives. Additionally, there may be discussions regarding the adequacy and fairness of regulatory review processes when multiple applicants vie for approval under revised exclusivity terms. These factors could influence both consumer markets and pharmaceutical innovations.
To amend the Federal Food, Drug, and Cosmetic Act to authorize requiring the manufacturers of a covered device to disclose to a patient all patient-specific data that is recorded or transmitted by the device and accessible to the manufacturer, and for other purposes.
To amend the Trademark Act of 1946 to clarify the applicability of Federal trademark law in the area of digital replicas of identifying characteristics of individuals, and for other purposes.
In personal income tax, further providing for classes of income and for special tax provisions for poverty and providing for alternative special tax provisions for poverty; in corporate net income tax, further providing for definitions, for imposition of tax, for reports and payment of tax, for consolidated reports and for manufacturing innovation and reinvestment deduction; in realty transfer tax, further providing for transfer of tax; in tax credit and tax benefit administration, further providing for definitions; in entertainment production tax credit, further providing for definitions, for credit for qualified film production expenses, for carryover, carryback and assignment of credit and for limitations; in Pennsylvania Economic Development for a Growing Economy (PA EDGE) tax credits, providing for biotechnology; in neighborhood assistance tax credit, further providing for tax credit and for grant of tax credit; providing for expanded neighborhood improvement zones; in Pennsylvania Child and Dependent Care Enhancement Tax Credit Program, further providing for credit for child and dependent care employment-related expenses; providing for Public Transportation Trust Fund; and, in general provisions, further providing for underpayment of estimated tax, for method of filing and for allocation of tax credits.