The Priority Review Voucher (“PRV”) program is a powerful incentive to encourage sponsors to develop treatments for conditions that are not ordinarily priorities for industry, such as infectious diseases for which there is no significant market in developed nations (tropical disease) or rare pediatric diseases. …
Identification of and comparison to a Reference Listed Drug (“RLD”) and Reference Standards (“RS”) are the lynchpin of generic drug development and approval. It’s therefore no surprise that, upon significantly updating the Orange Book in January 2017, FDA dedicated an entire guidance to fundamental definitions …
Back on August 20, 2020, the Drug Enforcement Administration (“DEA”) issued an Interim Final Rule (“IFR”) purporting to “clarify” certain provisions of the Agriculture Improvement Act of 2018 (“AIA”). As we explained back when Congress passed the AIA in December 2018, the AIA upended the …
2020 was supposed to be a year remembered for the 40th anniversary of the publication of the Orange Book—a celebration of one aspect of the Hatch-Waxman Amendments—but it could turn out that 2020 is remembered as the year in which the Hatch-Waxman Amendments took a …
Californovation (sung to the tune of the Red Hot Chili Peppers’ Californication, obviously): the new portmanteau seems appropriate for California, who just keeps coming up with new ideas to address the many hurdles consumers face with respect to access to affordable medicines. Last year, we …
Every so often, FDA revisits a policy set forth in FDA’s Manual of Policy and Procedures (“MAPP”) to reflect the Agency’s current practices. Though MAPPs really only govern the actions of the Agency, their content is important to understanding how FDA will approach certain requests. …
Earlier this week, FDA was supposed to issue proposed rules—years in the making—implementing over-the-counter (OTC) hearing aid rules, as required by the Food and Drug Administration Reauthorization Act (FDARA) (read HPM’s summary here). Under FDARA, FDA is required to issue proposed rules three years from …
When California first passed its Pay for Delay bill, AB 824: Preserving Access to Affordable Drugs, we questioned whether the law could withstand a constitutional challenge, and indeed, the Association for Accessible Medicines (“AAM”) brought such a challenge in November 2019. For those of you …
Initially enacted in 2012 and reauthorized for the first time in 2017, the Generic Drug User Fee Act (“GDUFA”) was adopted to accelerate access to safe and improve the predictability of the generic drug review process. FDA touts the GDUFA as a “remarkable success” that …
Much to our delight, the Orange Book is getting quite a bit of attention from FDA in 2020. And why not?!? After all, the Orange Book is celebrating its 40th anniversary this year. There was even a special “BPCIA Orange Book Transition Edition” published in …
Now that most of the country has been in lockdown for about two months, everyone is undoubtedly aware that COVID-19 has been declared an “official” public health emergency. In addition to the official declaration in January, HHS issued an additional and separate declaration – called …
The Pharmaceutical Manufacturing Research Services (“PMRS”) appears to abide by the proverb “If at first you can’t succeed, try try again.” After several denied Citizen Petitions, striking out in the Eastern District of Pennsylvania, and bringing then dismissing another suit against FDA in that same …
We’re a little late to the party on this one (let’s just blame it on social distancing), but, after 10 years in the making, Transition Day has finally come and gone for protein products. For the uninitiated, on March 23, 2020, all products approved as …
It’s no secret that FDA’s review and approval metrics are closely watched. In fact, these metrics are integral to evaluating whether FDA has met the commitment to industry it made during Prescription Drug User Fee Act (“PDUFA”) negotiations. As explained in our summary of the …
With the growth of biosimilar applications, courts have been faced with a litany of questions arising from the interplay between reference product intellectual property and the biosimilar application process. Though the BPCIA was designed to “learn” from FDA’s experience with the Hatch-Waxman Act, the procedural …
