Terence Young’s 13-year crusade for greater regulation of prescription drugs has lead to proposed legislation, tabled in Parliament on Friday, that will give Health Canada greater power policing unsafe health products in the marketplace. Young, the Conservative MP for Oakville, Ont., joined Rona Ambrose, Minister of Health, in a press conference to introduce the Protecting Canadians from Unsafe Drugs Act. The legislation will be known as “Vanessa’s Law,” after Young’s 15-year-old daughter, Vanessa, who died in 2000 of a heart attack caused by Prepulsid, a prescription drug later removed from market.
If passed, the legislation will set new standards for prescription and over-the-counter drugs, vaccines, gene therapies, cells, tissues and organs, and medical devices (“natural health products” will not be affected).
The legislation’s objectives include introducing mandatory reporting of adverse drug reactions from healthcare institutions, which includes hospitals and other facilities yet to be determined. This is a major change. Currently only manufacturers are required to submit reports of adverse reactions; it’s believed only a tiny fraction are reported, and it can take years for Health Canada to remove a dangerous drug from the market. The new legislation will also impose stiffer penalties on unsafe products and enable swifter regulatory action, such as a product recall or label change. The agency will be able to recall unsafe products; impose new penalties for unsafe products, including jail time and new fines of up to $5 million per day, up from the current $5,000; provide the courts with discretion to impose even stronger fines if violations were caused intentionally; compel drug companies to revise labels to clearly reflect health risk information; and compel drug companies to do further testing on a product, including when issues are identified with certain at-risk populations such as children.
Some of the new measures, such as increased fines and penalties, will become law immediately upon Royal Assent. Other changes to the Food and Drugs Act cannot come into force until supporting regulations are published.
At Friday’s press conference, Young, who militated for plain-language drug labelling introduced in June, and who has also advocated for an independent drug regulatory arm (currently drug approval is based on data supplied by the drugs’ manufacturers), expressed optimism: “It is difficult to overstate the impact this bill will have for Canadians who take prescription and over the counter drugs,” he said. “It represents a quantum leap forward in protecting vulnerable patients and reducing serious adverse drug reactions. It is absolutely necessary to reduce deaths and injuries caused by adverse drug reactions, 70 per cent of which are preventable, and will serve Canadians extremely well.”
Initial reaction from drug-safety experts is cautiously optimistic. “My impression is generally favourable, says David Juurlink, a Toronto physician with Sunnybrook Hospital and a scientist with the Institute for Clinical Evaluative Sciences. “If the elements are enacted, it would represent a considerable step forward from the status quo—which is pretty bad.” Some elements are more enforceable than others, he says: “I’m glad hospitals will have to report adverse reactions; it’s impractical to expect every family doctor to report every adverse reaction they see, though I hope they report it anyway.” He dismisses the notion that we’ll see drug company executives behind bars. ”Lawyers make deals to prevent that,” he says. ”People who go to jail sell marijuana in the street.”
The legislation is only useful if the adverse effects reports are used by Health Canada in “a meaningful, thoughtful and deliberate way,” Juurlink says, adding that he hopes the proposed legislation will increase transparency within the agency: “I don’t know what the heck happens behind the walls of Health Canada,” he says. “It’s an inscrutable black box. Their MedEffects data base is garbage. Hopefully the adverse-effects reports they receive will be sufficentially detailed to draw inferences from them. But would be nice if we knew what Health Canada was going to do with tsumani of reports they are going to get.”
Health Canada claims they’re ready for the influx: ”An influx would be a great thing for our scientists,” says David Lee, director, Office of Legislative and Regulatory Modernization, in an interview with Maclean’s. “They’re ready for that. We’ll be able to organize how information comes in and streamline that. We will do that in conversation with doctors and hospital pharmacists; that will make us more efficient.” As for changes to the agencies systems or staffing, there are no plans right now, he says: “We will be monitoring resources in department.”
Dr. Supriya Sharma, a senior medical adviser and assistant deputy minister, says that the new law will provide more “tools” for Health Canada to use. There will be no “magic number of adverse reactions that tip the balance” of a drug coming off the market, she says: “We have to look at the entirety of information. If a product issue comes up, we look at benefits and risks. Do the risks outweigh benefits? For example, with a cancer drug you’ll except higher level of risk than something used to treat a cold.” Under the proposed law, the agency could compel drug companies to provide information, something it couldn’t do before, she points out.
Lee says some new tools will be really helpful with “populations we can identify.” Not everybody taking a drug is in the same place, he says, citing a drug people might be taking for acid reflux where there’s lots of options. “But others, for example small children, are taking it for obstruction, a very serious condition. So do you make it available for those whose will be of great benefit but we have to put controls around risk. But if it’s a light indication for use we’ll take a more aggressive stance. This gives us tools to really act decisively.” It’s a fitting–and poignant–example. For it was an acid reflux drug taken for a non-serious indication and known to be a danger that killed Vanessa Young.
Sunday, December 8, 2013