AR184

An Assembly Resolution urging the United States Food and Drug Administration to expedite the approval process for generic drugs.

Whereas, The rising cost of health care has made it difficult for many Americans to afford medical treatment; and

Whereas, The federal government has demonstrated a commitment to lowering health care costs in order to make medical treatments more widely available; and

Whereas, Over four billion prescriptions are filled in the United States each year, many of which provide life-saving treatment and greatly improve the quality of life of those for whom they are prescribed; and

Whereas, Pro-patient, pro-science, pro-market reforms at the United States Food and Drug Administration (FDA) would enhance the competitive market for biopharmaceuticals, drive greater efficiency in drug development and discovery, and help hold down costs for payers and consumers; and

Whereas, Innovator companies invest in pioneering research to bring new treatments to patients, and over time those medicines become available as lower-cost generic copies; and

Whereas, Nearly 90 percent of all medicines dispensed to patients in the United States are generics and typically cost up to 90 percent less than the original brand medicine; and

Whereas, Consumers have increasingly opted for generic alternatives to brand name drugs, when available, since generic drugs are offered at a lower price than name brand drugs but provide the same benefit in most cases; and

Whereas, Although there are more than 7,000 new medicines in the biopharmaceutical pipeline and the FDA approved more than 40 new medicines in 2014, at the end of 2012, the FDA reported having a backlog of 2,866 generic drug applications, which must be reviewed before any new applications may be considered; and

Whereas, Once a drug’s patent expires, patients unable to afford life-saving drugs should not have to wait years for less-expensive generic alternatives to gain FDA approval; and

Whereas, Due to a significant backlog of abbreviated new drug applications (ANDAs) for generics at the FDA, on average it currently takes over four years for the FDA to act on a single application; and

Whereas, For serious diseases or conditions in small patient populations, lack of availability of effective medicines with no remaining patent life or regulatory exclusivity, coupled with no, or limited, brand or generic competition, may constitute an important public health risk; and

Whereas, To expedite access to generic drugs, for the next reauthorization of the Generic Drug User Fee Act (GDUFA), the FDA should consider additional steps to improve ANDA review efficiency, so that the current backlog of pending applications and the average time required to review generic drug applications can be reduced; now, therefore,

Be It Resolved by the General Assembly of the State of New Jersey:

1. The General Assembly of the State of New Jersey respectfully urges the United States Food and Drug Administration to expedite the approval process for generic drugs.

2. Copies of this resolution, as filed with the Secretary of State, shall be transmitted by the Clerk of the General Assembly to the Commissioner of the Food and Drug Administration.

STATEMENT

This resolution urges the United States Food and Drug Administration to expedite the generic drug approval process currently in place in order to make safe and inexpensive alternatives to expensive brand name drugs more readily available.

In recent years the cost of pharmaceuticals has increased. For many Americans, these rising costs can be offset by the availability of more inexpensive generic alternatives to name brand drugs. Under the current process, generic drug applications typically take years to be reviewed and approved. During that time, only the more expensive brand name drug, or in some cases, limited generic competitors, may be available, so there is little market competition to drive down the price of that drug.

It is the opinion of the sponsor that expediting the generic drug approval process would reduce health care costs while providing increased treatment options, objectives which the federal government has actively supported. In light of the recent extreme price gouging by Turing Pharmaceuticals CEO, Martin Shkreli, it is imperative that this issue be addressed as soon as possible to avoid any unnecessary death or prolonged illness.