Law gives needed attention to drug shortages

In such a heated election year, it is rare to see lawmakers from both political parties come together in overwhelming numbers to advance major federal legislation. But national drug shortages and other medication access issues are so pressing that Congress was able to put differences aside to approve a much-needed bill addressing several of them.

On July 9, President Obama signed the Food and Drug Administration Safety and Innovation Act, which passed in both houses nearly unanimously in late June. The main impetus behind the measure was the reauthorization of FDA drug and device user fee programs under which manufacturers pay the agency for expedited reviews of new therapies.

The continuation and modernization of those programs will enable needed medications and devices to come on the market sooner than if the FDA were to rely on its limited review budget alone. But the speed of the new approval pipeline is not the only important access issue facing patients and physicians. That’s why the law also takes crucial steps to address the pervasive problem posed by national drug shortages.

More than 200 drugs are considered to be in a state of nationwide shortage. Many of the drugs on the list are generic sterile injectibles that doctors administer in their offices or in clinics. This is not just an inconvenience for patients and the doctors trying to prescribe or administer the medications. Going without certain cancer treatments or anesthesia, for instance, is not an option for the patients who need them, and lives can hang in the balance.

The situation does not need to be this way. In many cases, an advance warning from a drug company that a medication was going to be pulled from the market or that a manufacturing problem was going to dry up the supply would be all the federal government needed to mitigate the potential shortage. The FDA then could take steps to help production come back online more quickly or to ask other manufacturers of the same or similar drugs to step up their production.

The great benefit of such advance warnings is why physician organizations, including the American Medical Association, supported an Obama executive order in October 2011 calling on drugmakers to give at least six months notice of a foreseeable potential shortage situation for a crucial drug. But physicians always said such a notice should not remain voluntary for drug companies. Delegates at the AMA Annual Meeting in Chicago in June adopted a resolution stating just that, and the enactment of the FDA Safety and Innovation Act follows that argument, making the advance warnings mandatory.

The law also addresses another AMA priority by including incentives for the production of next-generation antibiotics. Resistance to the current stable of antibiotics is a rapidly growing public health threat, and the number of drug companies that are working on the next versions of those medications has gone down to an alarming level. By changing the regulatory landscape to encourage more research, development and manufacture of these antibiotics, the law has the potential to turn this troublesome situation around.

Unfortunately, not all access to drugs is a good thing from a public health perspective. Recent surges in the use of “bath salts” and other synthetic forms of illicit drugs are worrisome to physicians because of the terrible health consequences they can have on patients, including hallucinations, violent behavior and death. By classifying these dangerous products as Schedule I controlled substances, the new law will allow law enforcement officials to crack down on them in a way that was not possible under the sparse patchwork of state statutes that preceded it.

The law also will direct the Dept. of Health and Human Services to review federal initiatives on drug diversion to see where there might be gaps in prevention efforts. The comptroller general, meanwhile, will be tasked with investigating rogue online pharmacies that break the law and threaten patient safety.

There is a fine line, however, between stamping out prescription drug abuse and building up roadblocks to patients who truly need those medications. That’s why Congress did the right thing by holding off on a proposal to reclassify hydrocodone as a Schedule II controlled substance, at least until after HHS holds a public hearing with patients, physicians and other stakeholders to discuss the best way to proceed. Physicians take the issue of drug abuse and diversion very seriously, but they also worry that patients in some care settings who have acute pain would suffer unnecessarily waiting for the physician signature that would be needed to release the drug to them.

Physicians will be watching closely to see how the new federal law will be implemented. For instance, the statute does not explicitly include biologics along with conventional drugs in the list of crucial therapies for which drugmakers will be required to give advance warnings of possible shortages. But the FDA has the power to make that addition when it goes through the rulemaking process to implement the provisions in the law.

In the meantime, patients can rest a bit easier knowing there will be new protections in place to ensure that they and their loved ones will have access to the medications and other products that can bolster their health and sustain their lives.