The jury is still out on the idea of interchangeability. However if there are any lessons to learn when it comes to man, nature and science, it is this: It is not nice to fool Mother Nature. On this issue the FDA got it right this time. Leave no stone unturned and no unknown variables left to chance — after all, there is a guide — Pharmaceutical CGMPs for the 21st Century - A RISK–BASED APPROACH.
At the absolute top of GPhA’s priorities is its mission to protect patient safety and access to affordable medicines. One of the biggest threats to these guiding principles, says GPhA, is the FDA’s proposed rule on prescription drug labeling. Unequivocally, GPhA opposes the proposed rule because it undermines the essential “sameness” of the label between generic and brand drugs mandated by law. According to GPhA president and CEO Neas, it is difficult to overstate the confusion that would be created among health care professionals and consumers if multiple versions of critical safety labeling information were to make their way into the marketplace.
Neas says GPhA is working with stakeholders and policy makers to ensure that the FDA’s proposed rule reflects sound policy, not politics. Given the present administration’s track record on creating policy that specifically supports its political agenda, chances are good this is going to be a tough row to hoe for GPhA and the industry. In his keynote remarks, Neas noted that in its rule making the Agency explicitly stated that the Mensing decision alters the incentive for generic drug manufacturers to comply with current requirements to conduct robust post-marketing surveillance evaluation and reporting and ensure that the labeling for the drugs is accurate and up-to-date. “With all due respect to the FDA and the Obama administration,” said Neas, “that is simply false, and frankly they know better.” Neas explained to attendees that it is not merely regulatory obligations that drive member’s compliance with current law: “Rather it is their design to provide clear, meaningful and up-to-date information about their products to patients and health care providers.”
Neas reminded attendees, including regulators in the room, that generic companies proactively participate with the FDA in ensuring the timeliness, accuracy and completeness of drug safety labeling in concurrence with regulatory requirements. “Sadly,” said Neas, “the FDA’s proposal, by opening the door to different labeling to be placed on prescription drugs, would create the very confusion it has sought to avoid for the past 30 years.” He noted that among consumers and patients, pharmacists and providers, the confusion would endanger patient safety. “Let me repeat that,” said Neas emphatically, “this confusion would endanger patient safety. Additionally, neither the FDA nor the Office of Management and Budget (OMB), conducted a cost/benefit analysis as the PMB is required to do.”
Economist Alex Brill of Matrix Global Advisors was commissioned by GPhA to investigate the economic impact of the proposed rule with regard to liability exposure and Mensing on the cost impact on public and private generic drug spending, should the rule become law. “His analysis shows that the proposed rule,” said Neas, “could increase spending on generic drugs by a staggering $4.1 billion per year. Of this, government health programs would take $1.5 billion and private health insurance would cover $2.6 billion.”
Neas and the GPhA maintain that the proposed rule adoption could result in fewer generic drugs coming to market, the withdrawal of manufacturers from certain markets, drug shortages and the under-adoption of affordable generic medicines and, ultimately, increased spending on drugs. “All of this,” said Neas, “is antithetical to the basic purposes of Hatch-Waxman. Moreover, it could raise costs for general therapies at a time when this country is focused on the need to further expand the accessibility of health care and reduce its accelerating costs.
According to GPhA, the industry group plans, in concert with its partners and other concerned groups (including former FDA officials said Neas) to take its case directly to regulators in its formal comments to the proposed rule.
THIRTY YEARS AND BEYOND
Few can argue that Generic Pharma won’t continue to play a prominent, leading role in the pharmaceutical drug industry. The advent of Hatch-Waxman has changed the pharmaceutical landscape forever — and in a good way. Certainly there are some less than positive aspects of the industry coming to light, especially those manufacturing in countries where the true culture of the industry, i.e., patient safety, is seemingly subordinate to profit motive. But there is no call, nor a need to indict the industry as a whole. Such bad actors are being called on to the carpet and singled out to atone for their sins, while others may soon be as regulators step up their scrutiny. In the meantime, it’s high time Generic Pharma exercise the leadership it has worked so hard to earn.