Beware of government agencies bearing gifts.
In this case, it’s the Food and Drug Administration that wants to bestow on the generic drug industry the power to change drug labeling any time it sees fit. These aren’t the labels on pill bottles we’re talking about; these are the longer, more critical and complicated labels doctors, pharmacists and other healthcare providers depend on to know about the drugs they are prescribing or providing to patients.
Specifically, through tenuous regulatory authority, the FDA wants to change the current law on drug labeling, which says that brand and generic drug labeling must be the same. Currently, if the maker of the original brand-name drug learns of a safety warning that needs to be added, it notifies the FDA and the FDA works with the manufacturer to change the labels quickly. Generic companies can provide safety information to the FDA about a drug, but even then, the FDA works with the original manufacturer on changes to the label.
Under the proposed rule, generic drug companies would be able to make changes to labels themselves. This approach could leave many manufacturers putting the revised labels on medicines even before the FDA ruled on whether the changes were appropriate.
The FDA is giddy at the prospect of starting the generic industry on this exciting new journey in labeling liberty. It says the proposed rule would promote better communication about drug safety among patients and providers and get new warnings into the hands of those who prescribe medicines more quickly. The rule is aimed at physicians and pharmacists, not patients.
Color the generic drug manufacturers underwhelmed. They say the new rule would create confusion. Labels for identical drugs could contain different sets of warnings. What one generic manufacturer might deem worthy of a warning another may not. This also will mean original branded drugs and the generics made with identical ingredients and processes would carry different labels until the conflicts were resolved.
This, say industry leaders, would set off an arms race of sorts as firms competed with each other to provide the most warnings. And this, of course, would incentivize exactly what the FDA and the people it serves do not want – inaccurate labeling.
“The confusion that will ensue has obvious implications for public health, which FDA has not addressed in its proposed rule,” stated the Generic Pharmaceutical Association in its commentary to the agency about the proposed rule. “FDA also did not conduct a robust cost/benefit analysis, and attempts to minimalize the potential that the proposed rule, if adopted, very likely will result in defensive labeling.”
Federal agencies are expert at coming up with fantastical justifications for their actions. No one is clamoring in the streets for this to happen. So what’s really pushing it? For one thing, since the law requires generic drug makers to have the same warnings on a label, they aren’t typically sued over labeling. There’s already a system where FDA monitors markets and drug companies — original and generic — report serious adverse events within 15 days.
And this has nothing to do with a battle between generic drug makers and the large pharmaceutical companies, because both agree this rule would be bad news and that labeling should be approved and controlled by the FDA.
Unfortunately, implicit in the liberty the FDA seeks to grant here is the responsibility on the part of generic manufacturers to, in essence, set out on their own in changing the label even though they didn’t do the original research on the drug and don’t have access to it now.
If drug makers get the authority to modify labels on drugs they didn’t develop, they become legally liable for any misinformation on those labels. That’s not fair and makes no sense – unless you’re a trial lawyer, in which case you’re looking at a huge initial payday and regular action thereafter.
It also means higher prices and less availability of some drugs, especially in particularly litigious areas, as generics companies would be more likely to back off riskier medicines for fear of lawsuits, as would the holders of a new drug patent.
Generics now account for 88 percent of prescriptions filled in America but for only about a quarter of what we spend on drugs. More than 14,000 drugs are available only in generic form. By one estimate, this new responsibility for the generic industry and the resulting increase in litigation would cost about $4 billion per year and result in fewer drugs being available.
Proponents say the fear of litigation, more than concern about confusion, drives the generic industry’s opposition to the rule. Others say the fears of five-page labels for every medication are overwrought, that its processes prevent creating a “laundry list” of irrelevant warnings on labels.
But the FDA has a mixed record on labeling already. The American Society of Health System Pharmacists says the agency “faces challenges maintaining consistent and current prescription drug labeling” and has had trouble enforcing past directives on labeling consistency.
In other words, there may be a tiny amount of risk in generics not rushing to put inconsistent labels on medicines. But there’s a lot bigger risk that if the current labeling system is thrown into chaos and generic manufacturers start backing off producing certain drugs, a lot of people will either lose access to drugs they need or have to pay far more for them.
Brian McNicoll is a conservative columnist and freelance writer based in Alexandria, Va. He is a former senior writer for The Heritage Foundation and former director of communications for the House Committee on Oversight and Government Reform. Thinking of submitting an op-ed to the Washington Examiner? Be sure to read our guidelines on submissions.
